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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Antigen, Control
510(k) Number K913342
Device Name AUTOSTAT(TM) ANTI-DSNA
Applicant
Cogent Diagnotics , Ltd.
Allanwater Business Centre
Stirling Rd.
Dunblane, Fk15 9ep,  GB
Applicant Contact MCGREGOR
Correspondent
Cogent Diagnotics , Ltd.
Allanwater Business Centre
Stirling Rd.
Dunblane, Fk15 9ep,  GB
Correspondent Contact MCGREGOR
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received07/26/1991
Decision Date 05/01/1992
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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