Medical Device Manufacturer · US , Abbott Park , IL

Abbott Laboratories - FDA 510(k) Cleared Devices

882 submissions · 867 cleared · Since 1976
882
Total
867
Cleared
0
Denied
347 devices
26-50 of 347
Cleared Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874 · LFR
Chemistry · 230d
Cleared Oct 06, 2011
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
K110579 · CDD
Chemistry · 219d
Cleared Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
K111023 · JIT
Chemistry · 58d
Cleared May 06, 2011
URIC ACID MODEL 3P39
K102568 · KNK
Chemistry · 241d
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 Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · CIT
Chemistry · 289d
Cleared Nov 22, 2006
CALCIUM
K062855 · CJY
Chemistry · 58d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · MMI
Chemistry · 76d
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 Sep 10, 2004
ABBOTT AXSYM TROPONIN-I ADV
K041811 · MMI
Chemistry · 66d
Cleared Aug 18, 2004
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL...
K041687 · JJX
Chemistry · 57d
Cleared Apr 15, 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · NBW
Chemistry · 16d
Cleared Mar 25, 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628 · NBW
Chemistry · 15d
Cleared Jan 08, 2004
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845 · NBW
Chemistry · 28d
Cleared Oct 06, 2003
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458 · JIT
Chemistry · 56d
Cleared Jul 02, 2003
C-REACTIVE PROTEIN (CRP)
K030899 · DCN
Chemistry · 100d
Cleared Apr 23, 2003
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD...
K023256 · NBW
Chemistry · 205d

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