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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 K852841
Device Name RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
Applicant
Smithkline Diagnostics, Inc.
485 Potrero Ave.
P.O. Box 61947
Sunnyvale,  CA  94086
Applicant Contact RONALD J SCHOENGOLD
Correspondent
Smithkline Diagnostics, Inc.
485 Potrero Ave.
P.O. Box 61947
Sunnyvale,  CA  94086
Correspondent Contact RONALD J SCHOENGOLD
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received07/05/1985
Decision Date 07/24/1985
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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