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
84 devices
26-50 of 84
Cleared Dec 19, 1994
IMX RUBELLA IGM ANTIBODY ASSAY
K931059 · LFX
Microbiology · 658d
Cleared Dec 19, 1994
ABBOTT CHAGAS ANTIBODY EIA
K933716 · MIU
Microbiology · 507d
Cleared Dec 19, 1994
AXSYM DIGOXIN
K944506 · KXT
Microbiology · 96d
Cleared Jul 22, 1992
ABBOTT STREP A CONTROLS
K922490 · GTY
Microbiology · 56d
Cleared Jul 16, 1992
TESTPACK PLUS STREP A
K922345 · GTZ
Microbiology · 58d
Cleared Nov 29, 1991
ABBOTT IMX TOXO IGM POSITIVE CONTROL
K913106 · LGD
Microbiology · 140d
Cleared Feb 26, 1991
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL
K910416 · LGD
Microbiology · 27d
Cleared Jul 27, 1990
IMX CMV IGM ANTIBODY ASSAY
K900473 · LFZ
Microbiology · 176d
Cleared Jul 27, 1990
IMX CMV IGG ANTIBODY ASSAY
K900474 · LFZ
Microbiology · 176d
Cleared May 11, 1990
TESTPACK PLUS STREP A
K901274 · GTZ
Microbiology · 53d
Cleared May 03, 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543 · LJC
Microbiology · 87d
Cleared Jul 25, 1989
ABBOTT TESTPACK CHLAMYDIA
K893676 · LJC
Microbiology · 70d
Cleared Jun 23, 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295 · LFX
Microbiology · 178d
Cleared Jun 23, 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297 · LFX
Microbiology · 178d
Cleared Jun 23, 1989
IMX TOXO IGG ANTIBODY ASSAY
K890031 · LGD
Microbiology · 170d
Cleared Jun 23, 1989
IMX TOXO IGM ANTIBODY ASSAY
K890032 · LGD
Microbiology · 170d
Cleared Jun 02, 1989
CHLAMYDIAZYME BLOCKING REAGENT
K892371 · LJC
Microbiology · 57d
Cleared Dec 16, 1988
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · LJC
Microbiology · 14d
Cleared Jul 25, 1988
ABBOTT TESTPACK CHLAMYDIA
K880783 · LJC
Microbiology · 150d
Cleared Jul 14, 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535 · LJC
Microbiology · 23d
Cleared Jul 12, 1988
ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL
K882534 · LIR
Microbiology · 21d
Cleared Jun 22, 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277 · GQG
Microbiology · 22d
Cleared May 23, 1988
CHLAMYDIAZYME(TM)
K880469 · LJC
Microbiology · 110d
Cleared May 13, 1988
ABBOTT CMV-M EIA KIT
K872881 · LKQ
Microbiology · 296d
Cleared May 06, 1988
ABBOTT TESTPACK RSV
K874127 · GQG
Microbiology · 206d

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