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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K990796
Device Name AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
Applicant
Cogent Diagnotics , Ltd.
Pentlands Science Park
Bush Loan, Penicuik
Midlothian, Scotland,  GB EH26 OPL
Applicant Contact DANIELLE M KNIGHT
Correspondent
Cogent Diagnotics , Ltd.
Pentlands Science Park
Bush Loan, Penicuik
Midlothian, Scotland,  GB EH26 OPL
Correspondent Contact DANIELLE M KNIGHT
Regulation Number866.5660
Classification Product Code
MOB  
Date Received03/10/1999
Decision Date 04/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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