CLEARBLUE EASY EASY READ 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 Easy Read Pregnancy Test.

Pre-market Notification Details

Device IDK041404
510k NumberK041404
Device Name:CLEARBLUE EASY EASY READ 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-26
Decision Date2004-06-08

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