Medical Device Manufacturer · GB , Dunblane, Fk15 9ep

Cogent Diagnotics , Ltd.

31 submissions · 31 cleared · Since 1992
31
Total
31
Cleared
0
Denied

Cogent Diagnotics , Ltd. — FDA 510(k) Submissions

Cogent Diagnotics , Ltd. has submitted 31 FDA 510(k) premarket notifications since 1992, of which 31 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Extractable Antinuclear Antibody, Antigen And Control, System, Test, Anticardiolipin Immunological, Immunochemical, Thyroglobulin Autoantibody, System, Test, Rheumatoid Factor, Test System, Antineutrophil Cytoplasmic Antibodies (anca) . Use the specialty filter in the sidebar to narrow results.

31 devices
1–25 of 31
AUTOSTAT II ENA-6 PROFILE ELISA
K003054 · LLL Extractable Antinuclear... · Immunology
Oct 2000 11d
AUTOSTAT II ENA-4 PROFILE ELISA
K003057 · LLL Extractable Antinuclear... · Immunology
Oct 2000 11d
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
K002215 · MOB Test System,... · Immunology
Sep 2000 66d
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
K993557 · DHR System, Test, Rheumatoid... · Immunology
Mar 2000 135d
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
K994338 · DHR System, Test, Rheumatoid... · Immunology
Feb 2000 42d
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
K993085 · MID System, Test,... · Immunology
Feb 2000 139d
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
K993304 · DHR System, Test, Rheumatoid... · Immunology
Dec 1999 63d
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
K992449 · MID System, Test,... · Immunology
Nov 1999 125d
AUTOSTAT II ANTI-GLIADIN IGA ELISA
K993086 · MST Antibodies, Gliadin · Immunology
Nov 1999 58d
AUTOSTAT II ANTI-GLIADIN IGG ELISA
K993087 · MST Antibodies, Gliadin · Immunology
Nov 1999 58d
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
K992440 · MID System, Test,... · Immunology
Sep 1999 61d
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
K991942 · MLE Enzyme Immunoassay,... · Immunology
Aug 1999 76d
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
K991890 · MVJ Devices, Measure,... · Immunology
Aug 1999 67d
AUTOSTAT II ANTI-SM/RNP ELISA
K990624 · LKO Anti-rnp Antibody,... · Immunology
Apr 1999 62d
AUTOSTAT II ANTI-SM ELISA
K990625 · LKP Anti-sm Antibody, Antigen... · Immunology
Apr 1999 62d
AUTOSTAT II ANTI-SS-B/LA ELISA
K990626 · LLL Extractable Antinuclear... · Immunology
Apr 1999 62d
AUTOSTAT II ANTI-SS-A/RO ELISA
K990627 · LLL Extractable Antinuclear... · Immunology
Apr 1999 62d
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
K990796 · MOB Test System,... · Immunology
Apr 1999 49d
AUTOSTAT II ANTI-SCL-70 ELISA
K990797 · LLL Extractable Antinuclear... · Immunology
Apr 1999 49d
AUTOSTAT II ANTI-JO-1 ELISA
K990798 · LLL Extractable Antinuclear... · Immunology
Apr 1999 49d
AUTOSTAT II ANA SCREEN ELISA
K983655 · LJM Antinuclear Antibody... · Immunology
Jan 1999 101d
AUTOSTAT II ENA SCREEN ELISA
K983921 · LLL Extractable Antinuclear... · Immunology
Dec 1998 54d
AUTOSTATTMII ANTI-DSDNA
K952567 · LRM Anti-dna Antibody... · Immunology
Mar 1997 638d
AUTOSTAT II ANTI-TPO
K943580 · JNL Immunochemical,... · Immunology
Apr 1995 269d
AUTOSTAT II ANTI-THYROGLOBULIN
K943625 · DDC Thyroglobulin, Antigen,... · Immunology
Dec 1994 149d
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