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 Mar 21, 1988
VISION(R) CRP
K875345 · DCK
Immunology · 82d
Cleared Aug 12, 1987
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K872800 · DEW
Immunology · 28d
Cleared Mar 16, 1987
VISION(TM) CRP
K864131 · DCK
Immunology · 146d
Cleared Nov 12, 1986
ABBOTT B2-MICROGLOBULIN RIA
K864130 · JZG
Immunology · 22d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT
K854944 · DAH
Immunology · 260d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
K855046 · CZP
Immunology · 253d
Cleared Feb 21, 1986
TDX TRANSFERRIN DIAGNOSTIC KIT
K854416 · DDG
Immunology · 109d
Cleared Jan 24, 1986
TDX C-REACTIVE PROTEIN
K854542 · DCK
Immunology · 72d
Cleared Jul 15, 1985
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K852589 · DEW
Immunology · 27d
Cleared May 20, 1985
ABBOTT HSV EIA
K843622 · LGC
Immunology · 248d
Cleared May 29, 1981
TOX TM ANALYZER
K811263 · JQZ
Immunology · 23d
Cleared May 05, 1981
RUBAZYME - M
K810835 · GOK
Immunology · 41d
Cleared Dec 19, 1980
CYBREX CARBAMAZEPINE
K802902 · KLT
Immunology · 32d
Cleared Aug 20, 1980
FERRIZYME FERRITIN ENZYME IMMUNOASSAY
K801676 · DBF
Immunology · 29d
Cleared Nov 27, 1979
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188 · CDX
Immunology · 27d
Cleared Apr 04, 1979
A-GENT-HDL REAGENT
K790329 · LBR
Immunology · 47d
Cleared Dec 20, 1977
DUAL WAVELENGTH PHOTOMETER, 1177
K771909 · JJQ
Immunology · 70d
Cleared Aug 03, 1977
TRIOBEAD-125 DIAGNOSTIC KIT
K771236 · CEC
Immunology · 23d
Cleared Apr 28, 1977
THYROSCREEN TM T4 DIAGNOSTIC KIT
K770474 · CDX
Immunology · 48d
Cleared Nov 16, 1976
TEST FOR DETECTION OF ANTIRUBELLA ANTIB
K760889 · GOL
Immunology · 21d
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