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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 K873784
Device Name NOVA STREP A
Applicant
Synbiotics Corp.
11011 Via Frontera
San Diego,  CA  92127
Applicant Contact RUTH A OTT
Correspondent
Synbiotics Corp.
11011 Via Frontera
San Diego,  CA  92127
Correspondent Contact RUTH A OTT
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received09/17/1987
Decision Date 11/12/1987
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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