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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K991828
Device Name STREP B OIA
Applicant
Biostar, Inc.
6655 Lookout Rd.
Boulder,  CO  80301
Applicant Contact ROGER C BRIDEN
Correspondent
Biostar, Inc.
6655 Lookout Rd.
Boulder,  CO  80301
Correspondent Contact ROGER C BRIDEN
Regulation Number866.3740
Classification Product Code
GTY  
Date Received05/28/1999
Decision Date 08/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
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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