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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 K843590
Device Name DETECT-A-STREP
Applicant
Antibodies, Inc.
P.O. Box 1560
Davis,  CA  95617
Applicant Contact JAY BANOVITZ
Correspondent
Antibodies, Inc.
P.O. Box 1560
Davis,  CA  95617
Correspondent Contact JAY BANOVITZ
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received09/12/1984
Decision Date 10/30/1984
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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