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Cogent Diagnotics , Ltd.

FDA 510(k) & PMA Approved Devices — 31 products

Total Devices31
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K003057 AUTOSTAT II ENA-4 PROFILE ELISALLL2000-10-13 View
510(k) K003054 AUTOSTAT II ENA-6 PROFILE ELISALLL2000-10-13 View
510(k) K002215 AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISAMOB2000-09-28 View
510(k) K993557 AUTOSTAT II RHEUMATOID FACTOR IGA ELISADHR2000-03-03 View
510(k) K994338 AUTOSTAT II RHEUMATOID FACTOR IGM ELISADHR2000-02-03 View
510(k) K993085 AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISAMID2000-02-01 View
510(k) K993304 AUTOSTAT II RHEUMATOID FACTOR IGG ELISADHR1999-12-06 View
510(k) K992449 AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISAMID1999-11-24 View
510(k) K993086 AUTOSTAT II ANTI-GLIADIN IGA ELISAMST1999-11-12 View
510(k) K993087 AUTOSTAT II ANTI-GLIADIN IGG ELISAMST1999-11-12 View
510(k) K992440 AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISAMID1999-09-21 View
510(k) K991942 AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISAMLE1999-08-24 View
510(k) K991890 AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISAMVJ1999-08-09 View
510(k) K990796 AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISAMOB1999-04-28 View
510(k) K990627 AUTOSTAT II ANTI-SS-A/RO ELISALLL1999-04-28 View
510(k) K990798 AUTOSTAT II ANTI-JO-1 ELISALLL1999-04-28 View
510(k) K990625 AUTOSTAT II ANTI-SM ELISALKP1999-04-28 View
510(k) K990797 AUTOSTAT II ANTI-SCL-70 ELISALLL1999-04-28 View
510(k) K990626 AUTOSTAT II ANTI-SS-B/LA ELISALLL1999-04-28 View
510(k) K990624 AUTOSTAT II ANTI-SM/RNP ELISALKO1999-04-28 View
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