FDA 510(k) Applications Submitted by ABBOTT LABORATORIES

FDA 510(k) Number Submission Date Device Name Applicant
K981806 05/21/1998 ALKP ABBOTT LABORATORIES
K012998 09/06/2001 AMPHETAMINE/METHAMPHETAMINE ABBOTT LABORATORIES
K013001 09/06/2001 METHADONE ABBOTT LABORATORIES
K013004 09/06/2001 COCAINE ABBOTT LABORATORIES
K013314 10/04/2001 OPIATES ABBOTT LABORATORIES
K013538 10/24/2001 ETHANOL ABBOTT LABORATORIES
K980367 01/29/1998 AEROSET SYSTEM ABBOTT LABORATORIES
K974779 12/22/1997 ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER ABBOTT LABORATORIES
K050103 01/18/2005 XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT LABORATORIES
K981060 03/23/1998 ABBOTT AXSYM 3RD GENERATION TSH ASSAY ABBOTT LABORATORIES
K983434 09/29/1998 ABBOTT ARCHITECT TOTAL T3 ABBOTT LABORATORIES
K983439 09/29/1998 ABBOTT ARCHITECT FREE T3 ABBOTT LABORATORIES
K983417 09/29/1998 ABBOTT ARCHITECT FREE T4 ABBOTT LABORATORIES
K983440 09/29/1998 ABBOTT ARCHITECT TOTAL T4 ABBOTT LABORATORIES
K983442 09/30/1998 ABBOTT ARCHITECT TSH ABBOTT LABORATORIES
K111874 07/01/2011 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS ABBOTT LABORATORIES
K201778 06/30/2020 i-STAT TBI Plasma cartridge with the i-STAT Alinity System Abbott Laboratories
K080696 03/12/2008 ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 ABBOTT LABORATORIES
K081231 05/01/2008 ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 ABBOTT LABORATORIES
K110909 03/31/2011 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. ABBOTT LABORATORIES
K001616 05/25/2000 MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE ABBOTT LABORATORIES
K962554 07/01/1996 FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE ABBOTT LABORATORIES
K963113 08/12/1996 FLEXIFLO POLYG GASTOSTOMY TUBE ABBOTT LABORATORIES
K110579 03/01/2011 ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS ABBOTT LABORATORIES
K092740 09/08/2009 ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 ABBOTT LABORATORIES
K121314 05/02/2012 ARCHITECT B12 ABBOTT LABORATORIES
K121003 04/02/2012 ABBOTT PLEX-ID FLU ASSAY ABBOTT LABORATORIES
K962467 06/25/1996 RV PACING LEAD ABBOTT LABORATORIES
K961552 04/22/1996 CVP POLYURETHANE CATHETER ABBOTT LABORATORIES
K961661 04/30/1996 OXIMETRIX 4 COMPUTER SYSTEM ABBOTT LABORATORIES
K955410 11/27/1995 SNAPDOSE DEVICE ABBOTT LABORATORIES
K123089 10/01/2012 FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 ABBOTT LABORATORIES
K952799 06/19/1995 ABBOTT XL3M INFUSION PUMP ABBOTT LABORATORIES
K982159 06/19/1998 ABBOTT PLUM A+ INFUSION PUMP ABBOTT LABORATORIES
K954283 09/05/1995 ENERGIZED CONTAINER SYSTEM (MODIFICATION) ABBOTT LABORATORIES
K974778 12/22/1997 ABBOTT GEMSTAR IV INFUSION PUMP ABBOTT LABORATORIES
K032458 08/11/2003 ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT ABBOTT LABORATORIES
K222850 09/21/2022 HAVAb IgG II ABBOTT LABORATORIES
K113719 12/19/2011 SAFETY SCREW CONNECTOR ABBOTT LABORATORIES
K010924 03/27/2001 MODIFICATION TO PLUM XL INFUSION PUMP ABBOTT LABORATORIES
K011096 04/10/2001 ABBOTT ACCLAIM ENCORE, MODEL 12237 ABBOTT LABORATORIES
K021350 04/29/2002 ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348 ABBOTT LABORATORIES
K011442 05/10/2001 ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 ABBOTT LABORATORIES
K021874 06/07/2002 ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 ABBOTT LABORATORIES
K022203 07/05/2002 ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 ABBOTT LABORATORIES
K024084 12/11/2002 ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 ABBOTT LABORATORIES
K072824 10/02/2007 FOX SV PTA CATHETER ABBOTT LABORATORIES
K971522 04/25/1997 ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II ABBOTT LABORATORIES
K963158 07/26/1996 ABBOTT AXSYM DIGITOXIN (MODIFY) ABBOTT LABORATORIES
K955444 11/28/1995 ABBOTT AXSM PROCAINAMIDE ASSAY ABBOTT LABORATORIES
K955422 11/28/1995 AXSYM N-ACETYLPROCAINAMIDE ABBOTT LABORATORIES
K955851 12/27/1995 AXSYM VANCOMYCIN II ABBOTT LABORATORIES
K040628 03/10/2004 PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM ABBOTT LABORATORIES
K982362 07/06/1998 ABBOTT TESTPACK PLUS H. PYLORI ABBOTT LABORATORIES
K123379 11/01/2012 ABBOTT ARCHITECT FREE T4 ABBOTT LABORATORIES
K010553 02/26/2001 PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY ABBOTT LABORATORIES
K022182 07/03/2002 MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM ABBOTT LABORATORIES
K023256 09/30/2002 PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO ABBOTT LABORATORIES
K021960 06/14/2002 PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY ABBOTT LABORATORIES
K012975 09/05/2001 SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS ABBOTT LABORATORIES
K980614 02/02/1998 ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS ABBOTT LABORATORIES
K991142 04/05/1999 CELL-DYN 1200 SYSTEM ABBOTT LABORATORIES
K981342 04/13/1998 ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY ABBOTT LABORATORIES
K992444 07/22/1999 MODIFICATION OF: CELL-DYN 1200 SYSTEM ABBOTT LABORATORIES
K955673 11/06/1995 CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) ABBOTT LABORATORIES
K955715 11/30/1995 CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) ABBOTT LABORATORIES
K983838 10/21/1998 ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP ABBOTT LABORATORIES
K994039 11/29/1999 ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB ABBOTT LABORATORIES
K000821 03/14/2000 ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION ABBOTT LABORATORIES
K991501 04/29/1999 ACCLAIM INFUSION PUMP ABBOTT LABORATORIES
K002126 07/14/2000 ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP ABBOTT LABORATORIES
K960466 01/02/1996 IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) ABBOTT LABORATORIES
K000886 03/20/2000 SPIROL EPIDURAL CATHETER ABBOTT LABORATORIES
K963351 08/26/1996 LIFESHIELD BLUNT CANNULA ABBOTT LABORATORIES
K050534 03/02/2005 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT LABORATORIES
K040667 03/15/2004 XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 ABBOTT LABORATORIES
K041962 07/21/2004 XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 ABBOTT LABORATORIES
K033537 11/10/2003 SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 ABBOTT LABORATORIES
K033909 12/17/2003 WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT LABORATORIES
K951541 04/03/1995 IMX RUBELLA IGG ABBOTT LABORATORIES
K952819 06/20/1995 ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) ABBOTT LABORATORIES
K953943 08/21/1995 AXSYM CMV IGG ANTIBODY ASSAY ABBOTT LABORATORIES
K954045 08/29/1995 AXSYM RUBELLA IGG ANTIBODY ASSAY ABBOTT LABORATORIES
K954575 10/02/1995 AXSYM TOXO IGG ANTIBODY ASSAY ABBOTT LABORATORIES
K954576 10/02/1995 AXSYM TOXO IGM ABBOTT LABORATORIES
K001993 06/29/2000 SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS ABBOTT LABORATORIES
K030513 02/19/2003 CELL-DYN 1800 SYSTEM ABBOTT LABORATORIES
K010953 03/30/2001 CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY ABBOTT LABORATORIES
K012934 08/31/2001 CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE ABBOTT LABORATORIES
K120009 01/03/2012 TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) ABBOTT LABORATORIES
K111023 04/13/2011 ABBOTT ARCHITECT LH CALIBRATORS ABBOTT LABORATORIES
K022941 09/03/2002 MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING ABBOTT LABORATORIES
K063329 11/03/2006 ABBOTT ARCHITECT HAVAB-M ABBOTT LABORATORIES
K963926 09/30/1996 AXSYM CA 15-3 ABBOTT LABORATORIES
K964020 10/07/1996 AXSYM CA 125 ABBOTT LABORATORIES
K955025 11/02/1995 AXSYM PROGESTERONE ABBOTT LABORATORIES
K964407 11/04/1996 IMX CA 15-3 ABBOTT LABORATORIES
K102699 09/20/2010 ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS ABBOTT LABORATORIES
K113704 12/16/2011 ARCHITECT HAVAB-G ABBOTT LABORATORIES
K130255 02/01/2013 HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS ABBOTT LABORATORIES
K140654 03/14/2014 Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls ABBOTT LABORATORIES
K103627 12/13/2010 ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS ABBOTT LABORATORIES
K990774 03/09/1999 ABBOTT ARCHITECT CEA ABBOTT LABORATORIES
K983212 09/14/1998 ABBOTT ARCHITECT TESTOSTERONE ABBOTT LABORATORIES
K983424 09/29/1998 ABBOTT ARCHEITECT TOTAL B-HCG ABBOTT LABORATORIES
K965116 12/20/1996 ABBOTT TESTPACK PLUS HCG COMBO WITH OBC ABBOTT LABORATORIES
K970082 01/09/1997 ABBOTT ADVISOR ONE-STEP PREGNANCY TEST ABBOTT LABORATORIES
K970527 02/11/1997 ABBOTT HCG SERUM CONTROLS ABBOTT LABORATORIES
K990373 02/08/1999 FACT PLUS ONE STEP PREGNANCY TEST ABBOTT LABORATORIES
K991483 04/28/1999 ABBOTT ARCHITECT GLYCATED HEMOGLOBIN ABBOTT LABORATORIES
K992085 06/21/1999 ABBOTT IMX GLYCATED HEMOGLOBIN II ABBOTT LABORATORIES
K992710 08/11/1999 ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK ABBOTT LABORATORIES
K062843 09/22/2006 FOX SV PTA CATHETER ABBOTT LABORATORIES
K041687 06/22/2004 ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR ABBOTT LABORATORIES
K061249 05/04/2006 AXSYM DIGOXIN III ABBOTT LABORATORIES
K051125 05/03/2005 IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 ABBOTT LABORATORIES
K173294 10/16/2017 Magnesium Abbott Laboratories
K983759 10/26/1998 ABBOTT ARCHITECT FERRITIN ABBOTT LABORATORIES
K972232 06/16/1997 ABBOTT AXSYM FOLATE ABBOTT LABORATORIES
K963827 09/24/1996 AXSYM FREE TRIIODOTHYRONINE (FREE T3) ABBOTT LABORATORIES
K963833 09/24/1996 IMX FREE TRIIODOTHYRONINE (FREE T3) ABBOTT LABORATORIES
K983848 10/30/1998 ABBOTT AXSYM MYOGLOBIN ABBOTT LABORATORIES
K974103 10/31/1997 ABBOTT AXSYM TROPONIN-I ABBOTT LABORATORIES
K984108 11/17/1998 ABBOTT ARCHITECT B12 ABBOTT LABORATORIES
K984301 12/02/1998 ABBOTT ARCHITECT FOLATE ABBOTT LABORATORIES
K965186 12/24/1996 AXSYM B12 ABBOTT LABORATORIES
K153375 11/23/2015 ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls ABBOTT LABORATORIES
K153730 12/28/2015 ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control Abbott Laboratories
K060295 02/06/2006 CARBON DIOXIDE ABBOTT LABORATORIES
K060383 02/14/2006 GLUCOSE ABBOTT LABORATORIES
K060574 03/06/2006 TOTAL BILIRUBIN ABBOTT LABORATORIES
K030899 03/24/2003 C-REACTIVE PROTEIN (CRP) ABBOTT LABORATORIES
K991372 04/20/1999 CRP ABBOTT LABORATORIES
K071525 06/04/2007 ACTIVATED ASPARTATE AMINOTRANSFERASE ABBOTT LABORATORIES
K982041 06/10/1998 UIBC ABBOTT LABORATORIES
K121985 07/06/2012 ARCHITECT TOTAL BILIRUBIN ABBOTT LABORATORIES
K051962 07/19/2005 ULTRA HDL ABBOTT LABORATORIES
K983070 09/02/1998 CK ABBOTT LABORATORIES
K012996 09/06/2001 BARBITURATES ABBOTT LABORATORIES
K983131 09/08/1998 AST ABBOTT LABORATORIES
K983133 09/08/1998 TBIL ABBOTT LABORATORIES
K983132 09/08/1998 IGM ABBOTT LABORATORIES
K983134 09/08/1998 NBIL ABBOTT LABORATORIES
K983167 09/10/1998 TRF ABBOTT LABORATORIES
K983221 09/14/1998 IGG ABBOTT LABORATORIES
K013100 09/17/2001 PROPOXYPHENE ABBOTT LABORATORIES
K013096 09/17/2001 PHENCYCLIDINE ABBOTT LABORATORIES
K983289 09/18/1998 APOLIPOPROTEIN A1 ABBOTT LABORATORIES
K983281 09/18/1998 APOB ABBOTT LABORATORIES
K013143 09/20/2001 BENZODIAZEPINES ABBOTT LABORATORIES
K983356 09/24/1998 C4 ABBOTT LABORATORIES
K983359 09/24/1998 IGA ABBOTT LABORATORIES
K062855 09/25/2006 CALCIUM ABBOTT LABORATORIES
K013247 09/28/2001 CANNABINOIDS ABBOTT LABORATORIES
K983441 09/30/1998 C3 ABBOTT LABORATORIES
K983774 10/26/1998 UALB ABBOTT LABORATORIES
K123372 11/01/2012 ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR ABBOTT LABORATORIES
K023807 11/14/2002 MODIFICATION TO ALKP ABBOTT LABORATORIES
K103403 11/19/2010 MULTICONSTITUENT CALIBRATOR ABBOTT LABORATORIES
K024067 12/10/2002 RHEUMATOID FACTOR (RF) ABBOTT LABORATORIES
K083809 12/22/2008 CREATININE ABBOTT LABORATORIES
K170160 01/18/2017 Abbott ARCHITECT Free T3 Abbott Laboratories
K170317 02/01/2017 Alinity i Total ▀-hCG Reagent Kit, Alinity i System ABBOTT LABORATORIES
K210596 03/01/2021 ARCHITECT Toxo IgG Abbott Laboratories
K173122 09/29/2017 Abbott Architect Free T4 Abbott Laboratories
K102568 09/07/2010 URIC ACID MODEL 3P39 ABBOTT LABORATORIES
K232669 09/01/2023 TBI Abbott Laboratories
K223602 12/02/2022 Traumatic brain injury (TBI) test Abbott Laboratories
K151566 06/10/2015 Abbott ARCHITECT Total T4 Calibrators ABBOTT LABORATORIES
K190294 02/11/2019 CELL-DYN Emerald 22 AL System Abbott Laboratories
K060875 03/30/2006 ABBOTT AXSYM TROPONIN-I ADV ABBOTT LABORATORIES
K051327 05/20/2005 ABBOTT AXSYM B12 ABBOTT LABORATORIES
K041811 07/06/2004 ABBOTT AXSYM TROPONIN-I ADV ABBOTT LABORATORIES
K992858 08/25/1999 ABBOTT AXSYM HOMOCYSTEINE ABBOTT LABORATORIES
K023397 10/09/2002 ABBOTT ARCHITECT FOLATE ABBOTT LABORATORIES
K053330 12/01/2005 ARCHITECT B12 CALIBRATORS ABBOTT LABORATORIES
K990035 01/06/1999 RF ABBOTT LABORATORIES
K981118 03/27/1998 PHOS ABBOTT LABORATORIES
K991175 03/29/1999 MODIFICATION TO ALCYON DIRECT BILIRUBIN ABBOTT LABORATORIES
K981185 04/02/1998 GLU ABBOTT LABORATORIES
K981189 04/02/1998 URIC ACID ABBOTT LABORATORIES
K981192 04/02/1998 MG ABBOTT LABORATORIES
K981216 04/03/1998 AMY ABBOTT LABORATORIES
K981218 04/03/1998 CREATINE KINASE (CK) ABBOTT LABORATORIES
K981221 04/03/1998 ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) ABBOTT LABORATORIES
K981222 04/03/1998 DIRECT BILIRUBIN (DBIL) ABBOTT LABORATORIES
K981224 04/03/1998 DIRECT HDL ABBOTT LABORATORIES
K981225 04/03/1998 ASPARTATE AMINOTRANSFERASE (AST) ABBOTT LABORATORIES
K981240 04/06/1998 CREATININE (CREA) ABBOTT LABORATORIES
K981241 04/06/1998 IRON ABBOTT LABORATORIES
K981245 04/06/1998 ALKALINE PHOSPHATASE (ALKP) ABBOTT LABORATORIES
K981279 04/08/1998 TIBC ABBOTT LABORATORIES
K981295 04/09/1998 UPRO ABBOTT LABORATORIES
K981303 04/10/1998 DIRECT LDL ABBOTT LABORATORIES
K981336 04/13/1998 TBIL ABBOTT LABORATORIES
K981467 04/23/1998 AMM ABBOTT LABORATORIES
K981468 04/23/1998 ALBG ABBOTT LABORATORIES
K981476 04/24/1998 CHOL ABBOTT LABORATORIES
K981580 05/04/1998 HDL ABBOTT LABORATORIES
K981581 05/04/1998 IRON ABBOTT LABORATORIES
K981578 05/04/1998 CA ABBOTT LABORATORIES
K981653 05/11/1998 AMY ABBOTT LABORATORIES
K981654 05/11/1998 TIBC ABBOTT LABORATORIES
K981652 05/11/1998 CHOL ABBOTT LABORATORIES
K981682 05/13/1998 UPRO ABBOTT LABORATORIES
K981706 05/14/1998 AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 ABBOTT LABORATORIES
K981758 05/19/1998 ALBG ABBOTT LABORATORIES
K981759 05/19/1998 PHOS ABBOTT LABORATORIES
K981766 05/19/1998 URIC ACID ABBOTT LABORATORIES
K981791 05/21/1998 MG ABBOTT LABORATORIES
K981799 05/21/1998 CREA ABBOTT LABORATORIES
K981814 05/22/1998 ALBP ABBOTT LABORATORIES
K981840 05/26/1998 CO2 ABBOTT LABORATORIES
K981843 05/26/1998 AST ABBOTT LABORATORIES
K981918 06/01/1998 UREA ABBOTT LABORATORIES
K981920 06/01/1998 AMM ABBOTT LABORATORIES
K981943 06/03/1998 DBIL ABBOTT LABORATORIES
K181748 07/02/2018 Magnesium Abbott Laboratories
K993083 09/15/1999 ALCYON 300I (WITH ISE MODULE) ANALYZER ABBOTT LABORATORIES
K093318 10/23/2009 ACCELERATOR APS ABBOTT LABORATORIES
K954301 08/23/1995 ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) ABBOTT LABORATORIES
K954318 09/15/1995 ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY ABBOTT LABORATORIES
K935833 12/07/1993 LCX NEISSERIA GONORRHOEAE ASSAY ABBOTT LABORATORIES
K936054 12/21/1993 IMX SELECT CHLAMYDIA ABBOTT LABORATORIES
K220282 02/01/2022 i-STAT PTplus Cartridge with the i-STAT 1 System Abbott Laboratories
K230790 03/22/2023 Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series Abbott Laboratories
K230937 04/03/2023 Alinity i Total ▀-hCG Reagent Kit, GLP systems Track Abbott Laboratories
K022180 07/03/2002 DIRECT BILIRUBIN ABBOTT LABORATORIES
K022339 07/18/2002 TOTAL BILIRUBIN ABBOTT LABORATORIES
K213486 10/29/2021 GLP systems Track Abbott Laboratories
K051215 05/12/2005 CELL-DYN SAPPHIRE SYSTEM ABBOTT LABORATORIES
K061667 06/14/2006 CELL-DYN RUBY SYSTEM ABBOTT LABORATORIES
K110381 02/10/2011 CELL-DYN EMERALD 22 SYSTEM ABBOTT LABORATORIES
K991605 05/10/1999 CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION ABBOTT LABORATORIES
K081495 05/29/2008 CELL-DYN EMERALD SYSTEM ABBOTT LABORATORIES
K981338 04/13/1998 LD-1 ABBOTT LABORATORIES
K220031 01/05/2022 Alinity h-series System Abbott Laboratories
K024126 12/16/2002 CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT ABBOTT LABORATORIES
K024239 12/23/2002 CHEMO DISPENSING PIN, MODEL 12495 ABBOTT LABORATORIES
K170316 02/01/2017 ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM Abbott Laboratories
K030002 01/02/2003 LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT. ABBOTT LABORATORIES
K040114 01/20/2004 ABBOTT DATA PORT PC, MODEL 12181 ABBOTT LABORATORIES
K031185 04/15/2003 ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE ABBOTT LABORATORIES
K041550 06/09/2004 HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE ABBOTT LABORATORIES
K033576 11/13/2003 LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE ABBOTT LABORATORIES
K974651 12/08/1997 ABBOTT AXSYM SYSTEM ABBOTT LABORATORIES
K152155 08/03/2015 ARCHITECT 2nd Generation Testosterone Abbott Laboratories
K150332 02/10/2015 FreeStyle Lite Blood Glucose Monitoring System ABBOTT LABORATORIES
K150531 03/02/2015 FreeStyle Freedom Lite Blood Glucose Monitoring System Abbott Laboratories
K152442 08/27/2015 Freestyle Freedom Blood Glucose Monitoring Sytem ABBOTT LABORATORIES
K220949 04/01/2022 Architect CMV IgG Abbott Laboratories
K971152 03/28/1997 ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) ABBOTT LABORATORIES
K972354 06/24/1997 ABBOTT CELL-DYN 3200 SYSTEM ABBOTT LABORATORIES
K150510 02/27/2015 Total Bilirubin ABBOTT LABORATORIES
K163342 11/29/2016 i-STAT Hematocrit test with i-STAT Alinity System Abbott Laboratories
K953805 08/08/1995 0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE ABBOTT LABORATORIES
K011217 04/20/2001 CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT ABBOTT LABORATORIES
K002006 07/03/2000 LIFESHIELD ADDITIVE PIERCING PIN ABBOTT LABORATORIES
K002717 08/31/2000 STERILE PISTON SYRINGE ABBOTT LABORATORIES
K040814 03/30/2004 MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM ABBOTT LABORATORIES
K033845 12/11/2003 PRECISION XCEED DIABETES MONITORING SYSTEM ABBOTT LABORATORIES
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