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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 (Enzyme-Labeled), Antigen, Controls
510(k) Number K983655
Device Name AUTOSTAT II ANA SCREEN 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 Number866.5100
Classification Product Code
LJM  
Date Received10/19/1998
Decision Date 01/28/1999
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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