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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 K936112
Device Name STREP B OIA
Applicant
Biostar, Inc.
6655 Lookout Rd.
Boulder,  CO  80301
Applicant Contact DAN W CHILDERS
Correspondent
Biostar, Inc.
6655 Lookout Rd.
Boulder,  CO  80301
Correspondent Contact DAN W CHILDERS
Regulation Number866.3740
Classification Product Code
GTY  
Date Received12/23/1993
Decision Date 07/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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