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Cogent Diagnotics , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K003054AUTOSTAT II ENA-6 PROFILE ELISAOctober 13, 2000
K003057AUTOSTAT II ENA-4 PROFILE ELISAOctober 13, 2000
K002215AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISASeptember 28, 2000
K993557AUTOSTAT II RHEUMATOID FACTOR IGA ELISAMarch 3, 2000
K994338AUTOSTAT II RHEUMATOID FACTOR IGM ELISAFebruary 3, 2000
K993085AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISAFebruary 1, 2000
K993304AUTOSTAT II RHEUMATOID FACTOR IGG ELISADecember 6, 1999
K992449AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISANovember 24, 1999
K993087AUTOSTAT II ANTI-GLIADIN IGG ELISANovember 12, 1999
K993086AUTOSTAT II ANTI-GLIADIN IGA ELISANovember 12, 1999
K992440AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISASeptember 21, 1999
K991942AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISAAugust 24, 1999
K991890AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISAAugust 9, 1999
K990798AUTOSTAT II ANTI-JO-1 ELISAApril 28, 1999
K990626AUTOSTAT II ANTI-SS-B/LA ELISAApril 28, 1999
K990796AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISAApril 28, 1999
K990624AUTOSTAT II ANTI-SM/RNP ELISAApril 28, 1999
K990797AUTOSTAT II ANTI-SCL-70 ELISAApril 28, 1999
K990625AUTOSTAT II ANTI-SM ELISAApril 28, 1999
K990627AUTOSTAT II ANTI-SS-A/RO ELISAApril 28, 1999