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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK990576
Test Name WYNTEK DIAGNOSTICS OSOM CARD PREGNANCY TEST, MODEL 103  
Manufacturer NameWyntek Diagnostics, Inc.
Consumer Information Phone NumberNO PHONE NUMBER
Test TypeUrine hCG by visual color comparison tests
Effective Date03/09/1999
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K990576
Device Name OSOM CARD PREGNANCY TEST, MODEL 103
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 Number862.1155
Classification Product Code
LCX  
Date Received02/23/1999
Decision Date 03/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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