FDA 510(k) Applications Submitted by BECKMAN COULTER, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K213517 |
11/03/2021 |
Access Thyroglobulin Antibody II |
Beckman Coulter, Inc. |
K000716 |
03/03/2000 |
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER |
BECKMAN COULTER, INC. |
K001935 |
06/26/2000 |
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 |
BECKMAN COULTER, INC. |
K000121 |
01/18/2000 |
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB |
BECKMAN COULTER, INC. |
K060130 |
01/18/2006 |
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT |
BECKMAN COULTER, INC. |
K010236 |
01/25/2001 |
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT |
BECKMAN COULTER, INC. |
K010358 |
02/06/2001 |
VIGIL SEROLOGY CONTROL LEVEL C |
BECKMAN COULTER, INC. |
K010597 |
02/28/2001 |
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT |
BECKMAN COULTER, INC. |
K990704 |
03/04/1999 |
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT |
BECKMAN COULTER, INC. |
K040767 |
03/25/2004 |
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT |
BECKMAN COULTER, INC. |
K140829 |
04/01/2014 |
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT |
BECKMAN COULTER, INC. |
K060935 |
04/05/2006 |
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT |
BECKMAN COULTER, INC. |
K011213 |
04/20/2001 |
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM |
BECKMAN COULTER, INC. |
K981638 |
05/08/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT |
BECKMAN COULTER, INC. |
K051307 |
05/19/2005 |
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT |
BECKMAN COULTER, INC. |
K121492 |
05/21/2012 |
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT |
BECKMAN COULTER, INC. |
K002799 |
09/08/2000 |
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 |
BECKMAN COULTER, INC. |
K023048 |
09/13/2002 |
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT |
BECKMAN COULTER, INC. |
K014034 |
12/07/2001 |
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) |
BECKMAN COULTER, INC. |
K024210 |
12/20/2002 |
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR |
BECKMAN COULTER, INC. |
K043556 |
12/27/2004 |
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT |
BECKMAN COULTER, INC. |
K141932 |
07/16/2014 |
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS |
BECKMAN COULTER, INC. |
K042281 |
08/24/2004 |
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY |
BECKMAN COULTER, INC. |
K140911 |
04/09/2014 |
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM |
BECKMAN COULTER, INC. |
K030012 |
01/02/2003 |
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 |
BECKMAN COULTER, INC. |
K050202 |
01/28/2005 |
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
K010428 |
02/13/2001 |
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 |
BECKMAN COULTER, INC. |
K010429 |
02/13/2001 |
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 |
BECKMAN COULTER, INC. |
K021814 |
06/03/2002 |
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 |
BECKMAN COULTER, INC. |
K033038 |
09/29/2003 |
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 |
BECKMAN COULTER, INC. |
K033036 |
09/29/2003 |
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 |
BECKMAN COULTER, INC. |
K021229 |
04/18/2002 |
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 |
BECKMAN COULTER, INC. |
K060774 |
03/22/2006 |
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 |
BECKMAN COULTER, INC. |
K052082 |
08/02/2005 |
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 |
BECKMAN COULTER, INC. |
K092505 |
08/14/2009 |
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 |
BECKMAN COULTER, INC. |
K080481 |
02/22/2008 |
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS |
BECKMAN COULTER, INC. |
K112603 |
09/07/2011 |
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
K112412 |
08/22/2011 |
AU5800(R) CHEMISTRY ANALYZER |
BECKMAN COULTER, INC. |
K080869 |
03/31/2008 |
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC |
BECKMAN COULTER, INC. |
K170524 |
02/22/2017 |
Access AMH |
Beckman Coulter, Inc. |
K012208 |
07/16/2001 |
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 |
BECKMAN COULTER, INC. |
K023093 |
09/18/2002 |
ACCESS HYPERSENSITIVE HTSH ASSAY |
BECKMAN COULTER, INC. |
K023369 |
10/08/2002 |
ACCESS TOTAL T4 ASSAY |
BECKMAN COULTER, INC. |
K023480 |
10/17/2002 |
ACCESS TOTAL BHCG |
BECKMAN COULTER, INC. |
K003259 |
10/18/2000 |
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 |
BECKMAN COULTER, INC. |
K223590 |
12/01/2022 |
Access Folate Assay |
Beckman Coulter, Inc. |
K142985 |
10/16/2014 |
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator |
BECKMAN COULTER, INC. |
K190109 |
01/23/2019 |
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) |
Beckman Coulter, Inc. |
K201423 |
05/29/2020 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ╡g/mL) |
Beckman Coulter, Inc. |
K202343 |
08/18/2020 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 ╡g/mL ) |
Beckman Coulter, Inc. |
K202423 |
08/25/2020 |
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 ╡g/mL) |
Beckman Coulter, Inc. |
K192355 |
08/29/2019 |
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) |
Beckman Coulter, Inc. |
K193358 |
12/04/2019 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) |
Beckman Coulter, Inc. |
K183127 |
11/13/2018 |
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) |
Beckman Coulter, Inc. |
K981864 |
05/27/1998 |
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 |
BECKMAN COULTER, INC. |
K981985 |
06/05/1998 |
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 |
BECKMAN COULTER, INC. |
K053090 |
11/02/2005 |
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR |
BECKMAN COULTER, INC. |
K053612 |
12/27/2005 |
DRI-STAT ACID PHOSPHATASE REAGENT |
BECKMAN COULTER, INC. |
K120771 |
03/14/2012 |
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM |
BECKMAN COULTER, INC. |
K000494 |
02/15/2000 |
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT |
BECKMAN COULTER, INC. |
K020521 |
02/19/2002 |
MODIFICATION TO VIGIL LIPID CONTROL |
BECKMAN COULTER, INC. |
K993022 |
09/09/1999 |
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS |
BECKMAN COULTER, INC. |
K993473 |
10/14/1999 |
SYNCHRON SYSTEMS DRUG CALIBRATOR 2 |
BECKMAN COULTER, INC. |
K003488 |
11/13/2000 |
SYNCHRON CONTROL |
BECKMAN COULTER, INC. |
K994325 |
12/22/1999 |
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
K000331 |
12/22/1999 |
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
K993023 |
09/09/1999 |
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS |
BECKMAN COULTER, INC. |
K130020 |
01/03/2013 |
ACCESS TOTAL BHCG (5TH IS) |
BECKMAN COULTER, INC. |
K112933 |
10/03/2011 |
ACCESS THYROGLOBULIN ANITBODY |
BECKMAN COULTER, INC. |
K000196 |
01/21/2000 |
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 |
BECKMAN COULTER, INC. |
K002453 |
08/10/2000 |
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 |
BECKMAN COULTER, INC. |
K080166 |
01/23/2008 |
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 |
BECKMAN COULTER, INC. |
K192271 |
08/22/2019 |
Access PCT, Access PCT Calibrators |
Beckman Coulter, Inc. |
K061282 |
05/08/2006 |
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 |
BECKMAN COULTER, INC. |
K172787 |
09/15/2017 |
Access hsTnl |
Beckman Coulter, Inc. |
K994278 |
12/20/1999 |
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY |
BECKMAN COULTER, INC. |
K121214 |
04/23/2012 |
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM |
BECKMAN COULTER, INC. |
K121790 |
06/18/2012 |
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM |
BECKMAN COULTER, INC. |
K111952 |
07/11/2011 |
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 |
BECKMAN COULTER, INC. |
K172783 |
09/15/2017 |
Access hs Tnl |
Beckman Coulter, Inc. |
K050119 |
01/18/2005 |
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT |
BECKMAN COULTER, INC. |
K031002 |
03/31/2003 |
SYNCHRON SYSTEMS OPIATE REAGENT |
BECKMAN COULTER, INC. |
K032035 |
07/01/2003 |
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI |
BECKMAN COULTER, INC. |
K032287 |
07/24/2003 |
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 |
BECKMAN COULTER, INC. |
K042195 |
08/13/2004 |
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 |
BECKMAN COULTER, INC. |
K042459 |
09/10/2004 |
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT |
BECKMAN COULTER, INC. |
K955434 |
10/02/1995 |
ACCESS FOLATE ASSAY (MODIFICATION) |
BECKMAN COULTER, INC. |
K221225 |
04/28/2022 |
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer |
Beckman Coulter, Inc. |
K223289 |
10/25/2022 |
Access Vitamin B12 |
Beckman Coulter, Inc. |
K223405 |
11/09/2022 |
Access Testosterone |
Beckman Coulter, Inc. |
K030291 |
01/28/2003 |
COULTER ACT 5DIFF AUTOLOADER (AL) |
BECKMAN COULTER, INC. |
K100607 |
03/03/2010 |
COULTER 4C-EX 300 CELL CONTROL |
BECKMAN COULTER, INC. |
K021150 |
04/10/2002 |
COULTER CELLPREP |
BECKMAN COULTER, INC. |
K071681 |
06/19/2007 |
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 |
BECKMAN COULTER, INC. |
K081822 |
06/27/2008 |
COULTER 6C CELL CONTROL, MODELS 628027 & A59925 |
BECKMAN COULTER, INC. |
K032013 |
06/30/2003 |
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
K081930 |
07/07/2008 |
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM |
BECKMAN COULTER, INC. |
K082162 |
07/31/2008 |
COULTER BODY FLUID CONTROL |
BECKMAN COULTER, INC. |
K042173 |
08/11/2004 |
COULTER A T 5DIFF CAP PIERCE (CP) |
BECKMAN COULTER, INC. |
K013842 |
11/20/2001 |
IMMUNO-TROL LOW CELLS |
BECKMAN COULTER, INC. |
K100790 |
03/22/2010 |
COULTER LIN-X LINEARITY CONTROL, MODEL A81196 |
BECKMAN COULTER, INC. |
K000410 |
02/08/2000 |
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS |
BECKMAN COULTER, INC. |
K000606 |
02/23/2000 |
SYNCHRON SYSTEMS AMPHETAMINE REAGENT |
BECKMAN COULTER, INC. |
K001458 |
05/10/2000 |
SYNCHRON CONTROL |
BECKMAN COULTER, INC. |
K982022 |
06/09/1998 |
VIGIL HEMOGLOBIN (HBALC) CONTROLS |
BECKMAN COULTER, INC. |
K982935 |
08/21/1998 |
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR |
BECKMAN COULTER, INC. |
K983209 |
09/14/1998 |
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I |
BECKMAN COULTER, INC. |
K003196 |
10/12/2000 |
SYNCHRON SYSTEMS AMMONIA REAGENT |
BECKMAN COULTER, INC. |
K983640 |
10/16/1998 |
SYNCHRON SYSTEMS LIPID CALIBRATOR |
BECKMAN COULTER, INC. |
K983709 |
10/21/1998 |
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 |
BECKMAN COULTER, INC. |
K983747 |
10/23/1998 |
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II |
BECKMAN COULTER, INC. |
K984014 |
11/11/1998 |
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 |
BECKMAN COULTER, INC. |
K984152 |
11/19/1998 |
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT |
BECKMAN COULTER, INC. |
K993954 |
11/22/1999 |
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS |
BECKMAN COULTER, INC. |
K984402 |
12/09/1998 |
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT |
BECKMAN COULTER, INC. |
K994169 |
12/10/1999 |
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
K994168 |
12/10/1999 |
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
K080634 |
03/06/2008 |
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 |
BECKMAN COULTER, INC. |
K031270 |
04/21/2003 |
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
K031269 |
04/21/2003 |
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
K031297 |
04/24/2003 |
ACCESS OV MONITOR ASSAY |
BECKMAN COULTER, INC. |
K031506 |
05/14/2003 |
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY |
BECKMAN COULTER, INC. |
K031606 |
05/22/2003 |
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY |
BECKMAN COULTER, INC. |
K032162 |
07/15/2003 |
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY |
BECKMAN COULTER, INC. |
K052223 |
08/15/2005 |
ACCESS EPO ASSAY |
BECKMAN COULTER, INC. |
K023764 |
11/12/2002 |
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 |
BECKMAN COULTER, INC. |
K051122 |
05/02/2005 |
ITAG MHC TETRAMER CMV ASSAY |
BECKMAN COULTER, INC. |
K012900 |
08/29/2001 |
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS |
BECKMAN COULTER, INC. |
K002905 |
09/18/2000 |
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER |
BECKMAN COULTER, INC. |
K003098 |
10/03/2000 |
ACCESS ULTRASENSITIVE HGH CALIBRATORS |
BECKMAN COULTER, INC. |
K023597 |
10/28/2002 |
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY |
BECKMAN COULTER, INC. |
K994277 |
12/20/1999 |
ACCESS OSTASE QC |
BECKMAN COULTER, INC. |
K110413 |
02/14/2011 |
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS |
BECKMAN COULTER, INC. |
K091153 |
04/21/2009 |
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 |
BECKMAN COULTER, INC. |
K091742 |
06/16/2009 |
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 |
BECKMAN COULTER, INC. |
K091846 |
06/22/2009 |
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 |
BECKMAN COULTER, INC. |
K082251 |
08/08/2008 |
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 |
BECKMAN COULTER, INC. |
K093458 |
11/06/2009 |
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 |
BECKMAN COULTER, INC. |
K103842 |
12/30/2010 |
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 |
BECKMAN COULTER, INC. |
K210127 |
01/19/2021 |
iQ200 System, iChemVELOCITY Automated Urine Chemistry System |
Beckman Coulter, Inc. |
K090588 |
03/04/2009 |
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 |
BECKMAN COULTER, INC. |
K011465 |
05/14/2001 |
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO |
BECKMAN COULTER, INC. |
K040181 |
01/27/2004 |
ACCESS DHEA-S REAGENT ASSAY |
BECKMAN COULTER, INC. |
K060256 |
02/01/2006 |
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM |
BECKMAN COULTER, INC. |
K010748 |
03/13/2001 |
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT |
BECKMAN COULTER, INC. |
K021572 |
05/14/2002 |
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR |
BECKMAN COULTER, INC. |
K031870 |
06/17/2003 |
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT |
BECKMAN COULTER, INC. |
K041643 |
06/17/2004 |
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT |
BECKMAN COULTER, INC. |
K042291 |
08/24/2004 |
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS |
BECKMAN COULTER, INC. |
K023049 |
09/12/2002 |
SYNCHRON LX I 725 CLINICAL SYSTEM |
BECKMAN COULTER, INC. |
K013076 |
09/14/2001 |
SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR |
BECKMAN COULTER, INC. |
K013235 |
09/28/2001 |
MODIFICATION TO SYNCHRON CONTROL |
BECKMAN COULTER, INC. |
K013978 |
12/03/2001 |
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT |
BECKMAN COULTER, INC. |
K014103 |
12/13/2001 |
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR |
BECKMAN COULTER, INC. |
K014173 |
12/20/2001 |
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR |
BECKMAN COULTER, INC. |
K153651 |
12/21/2015 |
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems |
BECKMAN COULTER, INC. |
K993210 |
09/24/1999 |
ACCESS HYBRITECH FREE PSA QC, MODEL 37219 |
BECKMAN COULTER, INC. |
K994200 |
12/13/1999 |
ACCESS HYBRITECH PSA QC, MODEL 37209 |
BECKMAN COULTER, INC. |
K994439 |
12/23/1999 |
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 |
BECKMAN COULTER, INC. |
K130253 |
02/01/2013 |
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION |
BECKMAN COULTER, INC. |
K130373 |
02/14/2013 |
NAVIOS FLOW CYTOMETER SYSTEM |
BECKMAN COULTER, INC. |
K060464 |
02/22/2006 |
COULTER 5C CELL CONTROL |
BECKMAN COULTER, INC. |
K061064 |
04/17/2006 |
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 |
BECKMAN COULTER, INC. |
K121445 |
05/15/2012 |
TETRACHROME REAGENTS AND TETRACXP SYSTEM |
BECKMAN COULTER, INC. |
K081526 |
06/02/2008 |
FLOWCARE TLG REAGENT |
BECKMAN COULTER, INC. |
K061574 |
06/07/2006 |
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 |
BECKMAN COULTER, INC. |
K061616 |
06/08/2006 |
COULTER LH 780 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
K081641 |
06/11/2008 |
COULTER LIN-X LINEARITY CONTROL |
BECKMAN COULTER, INC. |
K162414 |
08/29/2016 |
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System |
BECKMAN COULTER, INC. |
K140496 |
02/27/2014 |
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents |
BECKMAN COULTER, INC. |
K072612 |
09/17/2007 |
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 |
BECKMAN COULTER, INC. |
K010696 |
03/08/2001 |
BECKMAN COULTER DNASE B CALIBRATOR |
BECKMAN COULTER, INC. |
K982224 |
06/24/1998 |
VIGIL PROTEIN CONTROL |
BECKMAN COULTER, INC. |
K983151 |
09/09/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT |
BECKMAN COULTER, INC. |
K983340 |
09/23/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR |
BECKMAN COULTER, INC. |
K993547 |
10/19/1999 |
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB |
BECKMAN COULTER, INC. |
K993549 |
10/19/1999 |
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR |
BECKMAN COULTER, INC. |
K983895 |
11/03/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT |
BECKMAN COULTER, INC. |
K010693 |
03/08/2001 |
VIGIL DNASE B CONTROL |
BECKMAN COULTER, INC. |
K142373 |
08/25/2014 |
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst |
BECKMAN COULTER, INC. |
K142362 |
08/25/2014 |
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. |
BECKMAN COULTER, INC. |
K152346 |
08/20/2015 |
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) |
BECKMAN COULTER, INC. |
K162740 |
09/30/2016 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) |
BECKMAN COULTER, INC. |
K221493 |
05/23/2022 |
MicroScan Prompt Inoculation System-D |
Beckman Coulter, Inc. |
K010066 |
01/08/2001 |
5C-ES CELL CONTROL, MODELS 7547191, 7547192 |
BECKMAN COULTER, INC. |
K010064 |
01/08/2001 |
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 |
BECKMAN COULTER, INC. |
K050057 |
01/11/2005 |
COULTER LH 750 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
K030408 |
02/07/2003 |
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A |
BECKMAN COULTER, INC. |
K030606 |
02/25/2003 |
COULTER LH 750 BODY FLUIDS APPLICATION |
BECKMAN COULTER, INC. |
K010765 |
03/14/2001 |
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 |
BECKMAN COULTER, INC. |
K030828 |
03/14/2003 |
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) |
BECKMAN COULTER, INC. |
K011342 |
05/02/2001 |
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 |
BECKMAN COULTER, INC. |
K032000 |
06/10/2003 |
COULTER LH 500 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
K022161 |
07/03/2002 |
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 |
BECKMAN COULTER, INC. |
K032342 |
07/29/2003 |
COULTER LH 750 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
K042724 |
10/01/2004 |
MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
K052905 |
10/14/2005 |
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
K043215 |
11/19/2004 |
FLOWCARE PLG CD4 REAGENT |
BECKMAN COULTER, INC. |
K080812 |
03/24/2008 |
HEMOCCULT ICT |
BECKMAN COULTER, INC. |
K070626 |
03/06/2007 |
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT |
BECKMAN COULTER, INC. |
K071002 |
04/09/2007 |
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT |
BECKMAN COULTER, INC. |
K071280 |
05/07/2007 |
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS |
BECKMAN COULTER, INC. |
K071277 |
05/07/2007 |
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS |
BECKMAN COULTER, INC. |
K071283 |
05/07/2007 |
SYNCHRON SYSTEMS CREATININE REAGENT |
BECKMAN COULTER, INC. |
K172337 |
08/02/2017 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) |
Beckman Coulter, Inc. |
K062516 |
08/28/2006 |
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) |
BECKMAN COULTER, INC. |
K083867 |
12/29/2008 |
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND |
BECKMAN COULTER, INC. |
K070144 |
01/16/2007 |
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
K042651 |
09/28/2004 |
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
K033603 |
11/17/2003 |
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 |
BECKMAN COULTER, INC. |
K061190 |
04/28/2006 |
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 |
BECKMAN COULTER, INC. |
K061382 |
05/18/2006 |
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 |
BECKMAN COULTER, INC. |
K220178 |
01/21/2022 |
Total Immunoglobulin E (IgE) |
Beckman Coulter, Inc. |
K100010 |
01/04/2010 |
HDL CHOLESTEROL (HDLX) ASSAY |
BECKMAN COULTER, INC. |
K110251 |
01/28/2011 |
SYNCHRON MULTI CALIBRATOR |
BECKMAN COULTER, INC. |
K131189 |
04/26/2013 |
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) |
BECKMAN COULTER, INC. |
K103373 |
11/17/2010 |
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 |
BECKMAN COULTER, INC. |
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