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.
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K172337 08/02/2017 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) Beckman Coulter, Inc.
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