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
101-125 of 347
Cleared Jun 16, 1998
PHOS
K981759 · CEO
Chemistry · 28d
Cleared Jun 12, 1998
PHOS
K981118 · CEO
Chemistry · 77d
Cleared Jun 12, 1998
ALBG
K981758 · CIX
Chemistry · 24d
Cleared Jun 11, 1998
HDL
K981580 · LBS
Chemistry · 38d
Cleared Jun 08, 1998
AMY
K981216 · JFJ
Chemistry · 66d
Cleared Jun 08, 1998
IRON
K981581 · CFM
Chemistry · 35d
Cleared Jun 08, 1998
CO2
K981840 · KHS
Chemistry · 13d
Cleared May 29, 1998
CREATININE (CREA)
K981240 · CGX
Chemistry · 53d
Cleared May 27, 1998
ALBG
K981468 · CIX
Chemistry · 34d
Cleared May 20, 1998
ALKALINE PHOSPHATASE (ALKP)
K981245 · CJE
Chemistry · 44d
Cleared May 20, 1998
TIBC
K981279 · JMO
Chemistry · 42d
Cleared May 18, 1998
LD-1
K981338 · JGF
Chemistry · 35d
Cleared May 07, 1998
GLU
K981185 · CFR
Chemistry · 35d
Cleared May 07, 1998
URIC ACID
K981189 · CDO
Chemistry · 35d
Cleared May 01, 1998
MG
K981192 · JGJ
Chemistry · 29d
Cleared May 01, 1998
CREATINE KINASE (CK)
K981218 · CGS
Chemistry · 28d
Cleared May 01, 1998
IRON
K981241 · JIY
Chemistry · 25d
Cleared May 01, 1998
TBIL
K981336 · CIG
Chemistry · 18d
Cleared Apr 29, 1998
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
K981060 · JLW
Chemistry · 37d
Cleared Apr 24, 1998
DIRECT BILIRUBIN (DBIL)
K981222 · CIG
Chemistry · 21d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
K981221 · CIT
Chemistry · 20d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE (AST)
K981225 · CIT
Chemistry · 20d
Cleared Apr 01, 1998
AEROSET SYSTEM
K980367 · CGZ
Chemistry · 62d
Cleared Feb 13, 1998
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
K974779 · JJE
Chemistry · 53d
Cleared Feb 12, 1998
ABBOTT AXSYM SYSTEM
K974651 · JJE
Chemistry · 66d

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