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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 K961423
Device Name OSOM STREP A TEST
Applicant
Wyntek Diagnostics, Inc.
6145 Nancy Ridge Dr.
Suite 101
San Diego,  CA  92121
Applicant Contact SHU-CHING CHENG
Correspondent
Wyntek Diagnostics, Inc.
6145 Nancy Ridge Dr.
Suite 101
San Diego,  CA  92121
Correspondent Contact SHU-CHING CHENG
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received04/12/1996
Decision Date 10/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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