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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Direct Antigen, Positive Control
510(k) Number K972129
Device Name CHLAMYDIATROL AG
Applicant
Blackhawk Biosystems, Inc.
12945 Alcosta Blvd.
San Ramon,  CA  94583
Applicant Contact CAROLE POLITO
Correspondent
Blackhawk Biosystems, Inc.
12945 Alcosta Blvd.
San Ramon,  CA  94583
Correspondent Contact CAROLE POLITO
Regulation Number862.1660
Classification Product Code
MJZ  
Subsequent Product Code
MGM  
Date Received06/06/1997
Decision Date 08/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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