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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 K935475
Device Name QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU
Applicant
Syntron Bioresearch, Inc.
2774 Loker Ave. W.
Carlsbad,  CA  92008
Applicant Contact JAMES P LEE
Correspondent
Syntron Bioresearch, Inc.
2774 Loker Ave. W.
Carlsbad,  CA  92008
Correspondent Contact JAMES P LEE
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received11/15/1993
Decision Date 08/30/1995
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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