CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)

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 Pregnancy Testing Kit (modification).

Pre-market Notification Details

Device IDK864373
510k NumberK864373
Device Name:CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg,  GB
ContactGeorge Zajicek
CorrespondentGeorge Zajicek
UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg,  GB
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-05
Decision Date1987-01-09

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