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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 K924007
Device Name QUIKPAC STREP A TEST
Applicant
Syntron Bioresearch, Inc.
1080 Joshua Way
Vista,  CA  92083
Applicant Contact BENEDICT ZIN
Correspondent
Syntron Bioresearch, Inc.
1080 Joshua Way
Vista,  CA  92083
Correspondent Contact BENEDICT ZIN
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received08/10/1992
Decision Date 04/06/1993
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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