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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K993557
Device Name AUTOSTAT II RHEUMATOID FACTOR IGA 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 Number866.5775
Classification Product Code
DHR  
Date Received10/20/1999
Decision Date 03/03/2000
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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