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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK050930
Test Name Pfizer e.p.t Certainty Pregnancy Test  
Manufacturer NameUNIPATH LTD.
Consumer Information Phone Number(800)378-1783
Test TypeUrine hCG by visual color comparison tests
Effective Date05/19/2005
Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K050930
Device Name E.P.T. CERTAINTY PREGNANCY TEST
Applicant
UNIPATH LTD.
PRIORY BUSINESS PARK
BEDFORD,  GB MK44 3UP
Applicant Contact Louise Roberts
Correspondent
UNIPATH LTD.
PRIORY BUSINESS PARK
BEDFORD,  GB MK44 3UP
Correspondent Contact Louise Roberts
Regulation Number862.1155
Classification Product Code
LCX  
Date Received04/14/2005
Decision Date 05/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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