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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK954178
Test Name WYNTEK DIAGNOSTICS OSOM PREGNANCY TEST FOR HOME USE  
Manufacturer NameWyntek Diagnostics, Inc.
Consumer Information Phone NumberNO PHONE NUMBER
Test TypeUrine hCG by visual color comparison tests
Effective Date10/23/1995
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K954178
Device Name OSOM PREGNANCY TEST
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 Received09/05/1995
Decision Date 10/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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