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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K912889
Device Name OIA STREP A
Applicant
Biosearch Medical Products, Inc.
5766 Central Ave.
Flatiron Industrial Park
Boulder,  CO  80301
Applicant Contact DONALD L MEYER
Correspondent
Biosearch Medical Products, Inc.
5766 Central Ave.
Flatiron Industrial Park
Boulder,  CO  80301
Correspondent Contact DONALD L MEYER
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received07/01/1991
Decision Date 10/31/1991
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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