Medical Device Manufacturer · US , Abbott Park , IL

Abbott Laboratories - FDA 510(k) Cleared Devices

883 submissions · 868 cleared · Since 1976
883
Total
868
Cleared
0
Denied
883 devices
51-75 of 883
Cleared CT Apr 29, 2011
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY...
K110909 · NTE
Cardiovascular · 29d
Cleared Apr 01, 2011
ARCHITECT IGENTAMICIN REAGENTS
K102699 · LCD
Toxicology · 193d
Cleared Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
K103403 · JIX
Chemistry · 77d
Cleared Mar 05, 2010
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE...
K092740 · CGN
Chemistry · 178d
Cleared Feb 19, 2010
ACCELERATOR APS
K093318 · CEM
Chemistry · 119d
Cleared Apr 07, 2009
CREATININE
K083809 · CGX
Chemistry · 106d
Cleared Feb 04, 2009
CELL-DYN EMERALD SYSTEM
K081495 · GKZ
Hematology · 251d
Cleared Sep 26, 2008
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS,...
K081231 · DLZ
Toxicology · 148d
Cleared Sep 11, 2008
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH...
K080696 · DIP
Toxicology · 183d
Cleared Aug 19, 2008
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
K081549 · NTE
Cardiovascular · 77d
Cleared Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · CIT
Chemistry · 289d
Cleared Oct 23, 2007
FOX SV PTA CATHETER
K072824 · LIT
Cardiovascular · 21d
Cleared Apr 16, 2007
ABBOTT ARCHITECT HAVAB-M
K063329 · LOL
Microbiology · 164d
Cleared Nov 22, 2006
CALCIUM
K062855 · CJY
Chemistry · 58d
Cleared Oct 17, 2006
FOX SV PTA CATHETER
K062843 · LIT
Cardiovascular · 25d
Cleared Jul 10, 2006
CELL-DYN RUBY SYSTEM
K061667 · GKZ
Hematology · 26d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · MMI
Chemistry · 76d
Cleared Jun 02, 2006
AXSYM DIGOXIN III
K061249 · KXT
Toxicology · 29d
Cleared May 05, 2006
GLUCOSE
K060383 · CFR
Chemistry · 80d
Cleared May 04, 2006
CARBON DIOXIDE
K060295 · KHS
Chemistry · 87d
Cleared May 03, 2006
TOTAL BILIRUBIN
K060574 · CIG
Chemistry · 58d
Cleared Dec 16, 2005
ARCHITECT B12 CALIBRATORS
K053330 · JIT
Chemistry · 15d
Cleared Aug 25, 2005
ULTRA HDL
K051962 · LBS
Chemistry · 37d
Cleared Aug 03, 2005
ABBOTT AXSYM B12
K051327 · CDD
Chemistry · 75d
Cleared Jul 21, 2005
CELL-DYN SAPPHIRE SYSTEM
K051215 · GKZ
Hematology · 70d

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