Abbott Laboratories
FDA 510(k) medical device clearances.
Top product codes for Abbott Laboratories
Recent clearances by Abbott Laboratories
1–100 of 883- K252424 — Anti-HCV Next
- K243500 — ARCHITECT iGentamicin
- K243168 — Alinity i Rubella IgG
- K243283 — Alinity h-series System
- K233932 — Alinity i Toxo IgM
- K232669 — TBI
- K222850 — HAVAb IgG II
- K220031 — Alinity h-series System
- K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System
- K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track
- K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
- K223602 — Traumatic brain injury (TBI) test
- K220949 — Architect CMV IgG
- K210596 — ARCHITECT Toxo IgG
- K213486 — GLP systems Track
- K201778 — i-STAT TBI Plasma cartridge with the i-STAT Alinity System
- K190294 — CELL-DYN Emerald 22 AL System
- K181748 — Magnesium
- K173294 — Magnesium
- K173122 — Abbott Architect Free T4
- K170320 — Alinity c ICT Sample Diluent
- K170317 — Alinity i Total ß-hCG Reagent Kit, Alinity i System
- K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
- K163342 — i-STAT Hematocrit test with i-STAT Alinity System
- K170160 — Abbott ARCHITECT Free T3
- K153375 — ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
- K153730 — ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
- K152155 — ARCHITECT 2nd Generation Testosterone
- K152442 — Freestyle Freedom Blood Glucose Monitoring Sytem
- K151566 — Abbott ARCHITECT Total T4 Calibrators
- K150332 — FreeStyle Lite Blood Glucose Monitoring System
- K150531 — FreeStyle Freedom Lite Blood Glucose Monitoring System
- K140654 — Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
- K150510 — Total Bilirubin
- K130255 — HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
- K123089 — FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
- K121985 — ARCHITECT TOTAL BILIRUBIN
- K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
- K121003 — ABBOTT PLEX-ID FLU ASSAY
- K123379 — ABBOTT ARCHITECT FREE T4
- K120009 — TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
- K113704 — ARCHITECT HAVAB-G
- K121314 — ARCHITECT B12
- K113719 — SAFETY SCREW CONNECTOR
- K111874 — FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
- K110381 — CELL-DYN EMERALD 22 SYSTEM
- K103627 — ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
- K110579 — ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
- K111023 — ABBOTT ARCHITECT LH CALIBRATORS
- K102568 — URIC ACID MODEL 3P39
- K110909 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..
- K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
- K103403 — MULTICONSTITUENT CALIBRATOR
- K092740 — ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
- K093318 — ACCELERATOR APS
- K083809 — CREATININE
- K081495 — CELL-DYN EMERALD SYSTEM
- K081231 — ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33
- K080696 — ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
- K081549 — RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
- K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE
- K072824 — FOX SV PTA CATHETER
- K063329 — ABBOTT ARCHITECT HAVAB-M
- K062855 — CALCIUM
- K062843 — FOX SV PTA CATHETER
- K061667 — CELL-DYN RUBY SYSTEM
- K060875 — ABBOTT AXSYM TROPONIN-I ADV
- K061249 — AXSYM DIGOXIN III
- K060383 — GLUCOSE
- K060295 — CARBON DIOXIDE
- K060574 — TOTAL BILIRUBIN
- K053330 — ARCHITECT B12 CALIBRATORS
- K051962 — ULTRA HDL
- K051327 — ABBOTT AXSYM B12
- K051215 — CELL-DYN SAPPHIRE SYSTEM
- K051125 — IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
- K050534 — XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
- K050103 — XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
- K041962 — XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
- K041811 — ABBOTT AXSYM TROPONIN-I ADV
- K041687 — ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR
- K041550 — HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
- K040814 — MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
- K040667 — XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
- K040628 — PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
- K033909 — WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
- K040114 — ABBOTT DATA PORT PC, MODEL 12181
- K033845 — PRECISION XCEED DIABETES MONITORING SYSTEM
- K033537 — SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005
- K033576 — LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
- K032458 — ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT
- K030899 — C-REACTIVE PROTEIN (CRP)
- K030513 — CELL-DYN 1800 SYSTEM
- K031185 — ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
- K023256 — PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
- K030002 — LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.
- K024067 — RHEUMATOID FACTOR (RF)
- K024126 — CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
- K024239 — CHEMO DISPENSING PIN, MODEL 12495
- K024084 — ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
Data sourced from openFDA. This site is unofficial and independent of the FDA.