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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
510(k) Number K952567
Device Name AUTOSTATTMII ANTI-DSDNA
Applicant
Cogent Diagnotics , Ltd.
Kings Bldg.S, W. Mains Rd.
Edinburgh,  GB EH9 3JF
Applicant Contact JIM WESTON
Correspondent
Cogent Diagnotics , Ltd.
Kings Bldg.S, W. Mains Rd.
Edinburgh,  GB EH9 3JF
Correspondent Contact JIM WESTON
Regulation Number866.5100
Classification Product Code
LRM  
Date Received06/05/1995
Decision Date 03/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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