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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Infectious Mononucleosis
510(k) Number K972231
Device Name OSOM MONO TEST 143
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 Number866.5640
Classification Product Code
KTN  
Date Received06/16/1997
Decision Date 08/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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