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U.S. Department of Health and Human Services

OTC - Over The Counter

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Document NumberK042280
Test Name UNIPATH DIAGNOSTICS FACT PLUS ONE-STEP PREGNANCY TEST  
Manufacturer NameUNIPATH LTD.
Consumer Information Phone NumberNO PHONE NUMBER
Test TypeUrine hCG by visual color comparison tests
Effective Date09/14/2004
Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K042280
Device Name FACT PLUS ONE-STEP PREGNANCY TEST KIT
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 Received08/23/2004
Decision Date 09/10/2004
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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