FDA 510(k) Applications Submitted by COGENT DIAGNOTICS LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K003054 10/02/2000 AUTOSTAT II ENA-6 PROFILE ELISA COGENT DIAGNOTICS LTD.
K003057 10/02/2000 AUTOSTAT II ENA-4 PROFILE ELISA COGENT DIAGNOTICS LTD.
K990624 02/25/1999 AUTOSTAT II ANTI-SM/RNP ELISA COGENT DIAGNOTICS LTD.
K990625 02/25/1999 AUTOSTAT II ANTI-SM ELISA COGENT DIAGNOTICS LTD.
K990626 02/25/1999 AUTOSTAT II ANTI-SS-B/LA ELISA COGENT DIAGNOTICS LTD.
K990627 02/25/1999 AUTOSTAT II ANTI-SS-A/RO ELISA COGENT DIAGNOTICS LTD.
K990796 03/10/1999 AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA COGENT DIAGNOTICS LTD.
K990797 03/10/1999 AUTOSTAT II ANTI-SCL-70 ELISA COGENT DIAGNOTICS LTD.
K990798 03/10/1999 AUTOSTAT II ANTI-JO-1 ELISA COGENT DIAGNOTICS LTD.
K991890 06/03/1999 AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA COGENT DIAGNOTICS LTD.
K991942 06/09/1999 AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA COGENT DIAGNOTICS LTD.
K992440 07/22/1999 AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA COGENT DIAGNOTICS LTD.
K992449 07/22/1999 AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA COGENT DIAGNOTICS LTD.
K002215 07/24/2000 AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA COGENT DIAGNOTICS LTD.
K993086 09/15/1999 AUTOSTAT II ANTI-GLIADIN IGA ELISA COGENT DIAGNOTICS LTD.
K993087 09/15/1999 AUTOSTAT II ANTI-GLIADIN IGG ELISA COGENT DIAGNOTICS LTD.
K993304 10/04/1999 AUTOSTAT II RHEUMATOID FACTOR IGG ELISA COGENT DIAGNOTICS LTD.
K983655 10/19/1998 AUTOSTAT II ANA SCREEN ELISA COGENT DIAGNOTICS LTD.
K993557 10/20/1999 AUTOSTAT II RHEUMATOID FACTOR IGA ELISA COGENT DIAGNOTICS LTD.
K983921 11/04/1998 AUTOSTAT II ENA SCREEN ELISA COGENT DIAGNOTICS LTD.
K994338 12/23/1999 AUTOSTAT II RHEUMATOID FACTOR IGM ELISA COGENT DIAGNOTICS LTD.
K952567 06/05/1995 AUTOSTATTMII ANTI-DSDNA COGENT DIAGNOTICS LTD.
K993085 09/15/1999 AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA COGENT DIAGNOTICS LTD.


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