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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK122907
Test Name Polymed Therapeutics Fastep At-Home Pregnancy Test  
Manufacturer NamePolymed Therapeutics, Inc.
Consumer Information Phone Number1(800)777-7020
Test TypeUrine hCG by visual color comparison tests
Effective Date03/25/2013
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K122907
Device Name FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
Applicant
Polymed Therapeutics, Inc.
27001 La Paz Rd.
Suite 266b
Mission Viejo,  CA  92691
Applicant Contact TERRI WALLACE
Correspondent
Polymed Therapeutics, Inc.
27001 La Paz Rd.
Suite 266b
Mission Viejo,  CA  92691
Correspondent Contact TERRI WALLACE
Regulation Number862.1155
Classification Product Code
LCX  
Date Received09/21/2012
Decision Date 03/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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