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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK123703
Test Name SALESS ENTERPRISES INC., New Choice Pregnancy Test (Cassette)  
Manufacturer NameHealgen Scientific,, LLC
Consumer Information Phone Number1(800)351-0177
Test TypeUrine hCG by visual color comparison tests
Effective Date12/04/2018
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K123703
Device Name HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
Applicant
Healgen Scientific,, LLC
3818 Fuqua St.
Houston,  TX  77401
Applicant Contact BRYAN FANG
Correspondent
Healgen Scientific,, LLC
3818 Fuqua St.
Houston,  TX  77401
Correspondent Contact BRYAN FANG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received12/03/2012
Decision Date 04/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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