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
45 devices
26-45 of 45
Cleared Jun 09, 1995
ABBOTT VISION GLYCATED HB, MODIFICATION
K936285 · LCP
Hematology · 526d
Cleared Aug 09, 1993
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
K932127 · LGS
Hematology · 98d
Cleared Jul 14, 1993
ABBOTT ENCOUNTER(TM)Q
K930309 · GKZ
Hematology · 174d
Cleared Sep 29, 1992
IMX(R) GLYCATED HEMOGLOBIN
K921831 · LCP
Hematology · 166d
Cleared Feb 07, 1991
ABBOTT VISION(TM) GLYCATED HB
K904027 · LCP
Hematology · 161d
Cleared Aug 03, 1989
ABBOTT IMX(TM) D-DIMER
K893961 · GHH
Hematology · 63d
Cleared Mar 27, 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · GHH
Hematology · 60d
Cleared Sep 13, 1988
VISION(R) PROTHROMBIN TIME
K883441 · GJS
Hematology · 29d
Cleared Aug 18, 1986
VISION(TM) HEMOGLOBIN
K862202 · KHG
Hematology · 69d
Cleared Apr 17, 1984
RUBAQUICK DIAGNOSTIC KIT
K834032 · GOL
Hematology · 147d
Cleared May 05, 1983
PREALBUMIN ENZYME IMMUNOASSAY
K821135 · JZJ
Hematology · 380d
Cleared May 13, 1982
TDX TM STREPTOMYCIN
K821136 · LEH
Hematology · 23d
Cleared Apr 21, 1981
INTERFACE 20 MICRON TRANSFUSION BLD. F.
K810855 · CAK
Hematology · 22d
Cleared Jun 04, 1980
A-GENT QUANTICHROM THROMBIGEN I
K800725 · GGW
Hematology · 64d
Cleared May 30, 1980
A-GENT QUANTICHROM THROMBIGEN-E
K800656 · GGQ
Hematology · 66d
Cleared Apr 04, 1980
ADD OF RETICULOCYTE COUNT/CAPABILITIES
K800533 · GKZ
Hematology · 28d
Cleared Oct 17, 1979
A-GENT GLYCOSPEC
K791642 · LCP
Hematology · 55d
Cleared Nov 16, 1977
IN-LINE BURETTE SET
K772036 · FPA
Hematology · 20d
Cleared Nov 09, 1977
DIAG. KIT FOR TOTAL ANTITHROMBIN III
K771669 · JBQ
Hematology · 69d
Cleared Aug 04, 1977
AUTO DIFFERENTIAL CELL COUNTER SYSTEM
K770244 · GKZ
Hematology · 178d
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