CLEARPLAN EASY OVULATION TEST

Radioimmunoassay, Luteinizing Hormone

UNIPATH LTD.

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

Pre-market Notification Details

Device IDK981271
510k NumberK981271
Device Name:CLEARPLAN EASY OVULATION TEST
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant UNIPATH LTD. PRIORY BUSINESS PARK Bedford,  GB Mk44 3up
ContactLouise Roberts
CorrespondentLouise Roberts
UNIPATH LTD. PRIORY BUSINESS PARK Bedford,  GB Mk44 3up
Product CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-07
Decision Date1998-06-25

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