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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K974613
Device Name VIROTROL III
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
JJY  
Date Received12/11/1997
Decision Date 01/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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