CLEARBLUE EASY DIGITAL PREGNANCY TEST

Kit, Test, Pregnancy, Hcg, Over The Counter

UNIPATH LTD.

The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearblue Easy Digital Pregnancy Test.

Pre-market Notification Details

Device IDK030659
510k NumberK030659
Device Name:CLEARBLUE EASY DIGITAL PREGNANCY TEST
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant UNIPATH LTD. PRIORY BUSINESS PARK Bedford,  GB Mk44 3up
ContactLouise Roberts
CorrespondentLouise Roberts
UNIPATH LTD. PRIORY BUSINESS PARK Bedford,  GB Mk44 3up
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-03
Decision Date2003-05-02

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