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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 K915758
Device Name STREP A OIA
Applicant
Biosearch Medical Products, Inc.
5766 Central Ave.
Flatiron Industrial Park
Boulder,  CO  80301
Applicant Contact LYNDAL K HESTERBERG
Correspondent
Biosearch Medical Products, Inc.
5766 Central Ave.
Flatiron Industrial Park
Boulder,  CO  80301
Correspondent Contact LYNDAL K HESTERBERG
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received12/23/1991
Decision Date 01/30/1992
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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