MODIFICATION TO E.P.T. 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 Modification To E.p.t. Pregnancy Test.

Pre-market Notification Details

Device IDK040329
510k NumberK040329
Device Name:MODIFICATION TO E.P.T. 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 Received2004-02-11
Decision Date2004-03-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00363736953034 K040329 000
00363736952020 K040329 000

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