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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K992658
Device Name OSOM ULTRA STREP A TEST, MODEL 147
Applicant
Wyntek Diagnostics, Inc.
6146 Nancy Ridge Dr.,
Suite 101
San Diego,  CA  92121
Applicant Contact SHU-CHING CHENG
Correspondent
Wyntek Diagnostics, Inc.
6146 Nancy Ridge Dr.,
Suite 101
San Diego,  CA  92121
Correspondent Contact SHU-CHING CHENG
Regulation Number866.3740
Classification Product Code
GTY  
Date Received08/09/1999
Decision Date 01/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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