| Anti-HCV Next (K252424) | Abbott Laboratories | 2026-04-28 |
| ARCHITECT iGentamicin (K243500) | Abbott Laboratories | 2025-07-09 |
| Alinity i Rubella IgG (K243168) | Abbott Laboratories | 2025-06-20 |
| Alinity h-series System (K243283) | Abbott Laboratories | 2025-02-20 |
| Alinity i Toxo IgM (K233932) | Abbott Laboratories | 2024-08-30 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| HAVAb IgG II (K222850) | Abbott Laboratories | 2023-08-10 |
| Alinity h-series System (K220031) | Abbott Laboratories | 2023-08-04 |
| i-STAT PTplus Cartridge with the i-STAT 1 System (K220282) | Abbott Laboratories | 2023-07-14 |
| Alinity i Total ß-hCG Reagent Kit, GLP systems Track (K230937) | Abbott Laboratories | 2023-06-05 |
| Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790) | Abbott Laboratories | 2023-05-19 |
| Traumatic brain injury (TBI) test (K223602) | Abbott Laboratories | 2023-03-02 |
| Architect CMV IgG (K220949) | Abbott Laboratories | 2022-10-27 |
| ARCHITECT Toxo IgG (K210596) | Abbott Laboratories | 2022-05-19 |
| GLP systems Track (K213486) | Abbott Laboratories | 2022-03-10 |
| i-STAT TBI Plasma cartridge with the i-STAT Alinity System (K201778) | Abbott Laboratories | 2021-01-08 |
| CELL-DYN Emerald 22 AL System (K190294) | Abbott Laboratories | 2019-03-15 |
| Magnesium (K181748) | Abbott Laboratories | 2018-09-12 |
| Magnesium (K173294) | Abbott Laboratories | 2018-05-18 |
| Abbott Architect Free T4 (K173122) | Abbott Laboratories | 2017-10-27 |
| Alinity c ICT Sample Diluent (K170320) | Abbott Laboratories | 2017-10-24 |
| Alinity i Total ß-hCG Reagent Kit, Alinity i System (K170317) | Abbott Laboratories | 2017-10-23 |
| ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM (K170316) | Abbott Laboratories | 2017-10-19 |
| i-STAT Hematocrit test with i-STAT Alinity System (K163342) | Abbott Laboratories | 2017-08-22 |
| Abbott ARCHITECT Free T3 (K170160) | Abbott Laboratories | 2017-02-15 |
| ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls (K153375) | Abbott Laboratories | 2016-08-12 |
| ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control (K153730) | Abbott Laboratories | 2016-06-15 |
| ARCHITECT 2nd Generation Testosterone (K152155) | Abbott Laboratories | 2015-12-17 |
| Freestyle Freedom Blood Glucose Monitoring Sytem (K152442) | Abbott Laboratories | 2015-12-17 |
| Abbott ARCHITECT Total T4 Calibrators (K151566) | Abbott Laboratories | 2015-07-10 |
| FreeStyle Lite Blood Glucose Monitoring System (K150332) | Abbott Laboratories | 2015-06-05 |
| FreeStyle Freedom Lite Blood Glucose Monitoring System (K150531) | Abbott Laboratories | 2015-06-05 |
| Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls (K140654) | Abbott Laboratories | 2015-05-22 |
| Total Bilirubin (K150510) | Abbott Laboratories | 2015-04-02 |
| HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS (K130255) | Abbott Laboratories | 2014-02-28 |
| FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 (K123089) | Abbott Laboratories | 2013-04-05 |
| ARCHITECT TOTAL BILIRUBIN (K121985) | Abbott Laboratories | 2013-02-01 |
| ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (K123372) | Abbott Laboratories | 2013-01-14 |
| ABBOTT PLEX-ID FLU ASSAY (K121003) | Abbott Laboratories | 2012-12-21 |
| ABBOTT ARCHITECT FREE T4 (K123379) | Abbott Laboratories | 2012-11-27 |
| TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) (K120009) | Abbott Laboratories | 2012-09-11 |
| ARCHITECT HAVAB-G (K113704) | Abbott Laboratories | 2012-06-28 |
| ARCHITECT B12 (K121314) | Abbott Laboratories | 2012-05-17 |
| SAFETY SCREW CONNECTOR (K113719) | Abbott Laboratories | 2012-04-20 |
| FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS (K111874) | Abbott Laboratories | 2012-02-16 |
| CELL-DYN EMERALD 22 SYSTEM (K110381) | Abbott Laboratories | 2011-12-22 |
| ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS (K103627) | Abbott Laboratories | 2011-10-14 |
| ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS (K110579) | Abbott Laboratories | 2011-10-06 |
| ABBOTT ARCHITECT LH CALIBRATORS (K111023) | Abbott Laboratories | 2011-06-10 |
| URIC ACID MODEL 3P39 (K102568) | Abbott Laboratories | 2011-05-06 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. (K110909) | Abbott Laboratories | 2011-04-29 |
| ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (K102699) | Abbott Laboratories | 2011-04-01 |
| MULTICONSTITUENT CALIBRATOR (K103403) | Abbott Laboratories | 2011-02-04 |
| ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 (K092740) | Abbott Laboratories | 2010-03-05 |
| ACCELERATOR APS (K093318) | Abbott Laboratories | 2010-02-19 |
| CREATININE (K083809) | Abbott Laboratories | 2009-04-07 |
| CELL-DYN EMERALD SYSTEM (K081495) | Abbott Laboratories | 2009-02-04 |
| ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 (K081231) | Abbott Laboratories | 2008-09-26 |
| ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 (K080696) | Abbott Laboratories | 2008-09-11 |
| RX ACCUNET LP EMBOLIC PROTECTION SYSTEM (K081549) | Abbott Laboratories | 2008-08-19 |
| ACTIVATED ASPARTATE AMINOTRANSFERASE (K071525) | Abbott Laboratories | 2008-03-19 |
| FOX SV PTA CATHETER (K072824) | Abbott Laboratories | 2007-10-23 |
| ABBOTT ARCHITECT HAVAB-M (K063329) | Abbott Laboratories | 2007-04-16 |
| CALCIUM (K062855) | Abbott Laboratories | 2006-11-22 |
| FOX SV PTA CATHETER (K062843) | Abbott Laboratories | 2006-10-17 |
| CELL-DYN RUBY SYSTEM (K061667) | Abbott Laboratories | 2006-07-10 |
| ABBOTT AXSYM TROPONIN-I ADV (K060875) | Abbott Laboratories | 2006-06-14 |
| AXSYM DIGOXIN III (K061249) | Abbott Laboratories | 2006-06-02 |
| GLUCOSE (K060383) | Abbott Laboratories | 2006-05-05 |
| CARBON DIOXIDE (K060295) | Abbott Laboratories | 2006-05-04 |
| TOTAL BILIRUBIN (K060574) | Abbott Laboratories | 2006-05-03 |
| ARCHITECT B12 CALIBRATORS (K053330) | Abbott Laboratories | 2005-12-16 |
| ULTRA HDL (K051962) | Abbott Laboratories | 2005-08-25 |
| ABBOTT AXSYM B12 (K051327) | Abbott Laboratories | 2005-08-03 |
| CELL-DYN SAPPHIRE SYSTEM (K051215) | Abbott Laboratories | 2005-07-21 |
| IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 (K051125) | Abbott Laboratories | 2005-06-08 |
| XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050534) | Abbott Laboratories | 2005-05-20 |
| XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050103) | Abbott Laboratories | 2005-02-16 |
| XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 (K041962) | Abbott Laboratories | 2004-10-01 |
| ABBOTT AXSYM TROPONIN-I ADV (K041811) | Abbott Laboratories | 2004-09-10 |
| ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR (K041687) | Abbott Laboratories | 2004-08-18 |
| HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K041550) | Abbott Laboratories | 2004-06-30 |
| MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM (K040814) | Abbott Laboratories | 2004-04-15 |
| XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 (K040667) | Abbott Laboratories | 2004-04-07 |
| PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM (K040628) | Abbott Laboratories | 2004-03-25 |
| WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM (K033909) | Abbott Laboratories | 2004-02-17 |
| ABBOTT DATA PORT PC, MODEL 12181 (K040114) | Abbott Laboratories | 2004-01-29 |
| PRECISION XCEED DIABETES MONITORING SYSTEM (K033845) | Abbott Laboratories | 2004-01-08 |
| SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 (K033537) | Abbott Laboratories | 2003-12-10 |
| LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE (K033576) | Abbott Laboratories | 2003-12-04 |
| ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT (K032458) | Abbott Laboratories | 2003-10-06 |
| C-REACTIVE PROTEIN (CRP) (K030899) | Abbott Laboratories | 2003-07-02 |
| CELL-DYN 1800 SYSTEM (K030513) | Abbott Laboratories | 2003-05-12 |
| ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE (K031185) | Abbott Laboratories | 2003-04-30 |
| PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO (K023256) | Abbott Laboratories | 2003-04-23 |
| LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT. (K030002) | Abbott Laboratories | 2003-01-27 |
| RHEUMATOID FACTOR (RF) (K024067) | Abbott Laboratories | 2003-01-15 |
| CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT (K024126) | Abbott Laboratories | 2003-01-14 |
| CHEMO DISPENSING PIN, MODEL 12495 (K024239) | Abbott Laboratories | 2003-01-13 |
| ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 (K024084) | Abbott Laboratories | 2002-12-31 |