CLEARPLAN EASY FERTILITY MONITOR

Test, Luteinizing Hormone (lh), Over The Counter

UNIPATH LTD.

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

Pre-market Notification Details

Device IDK981207
510k NumberK981207
Device Name:CLEARPLAN EASY FERTILITY MONITOR
ClassificationTest, Luteinizing Hormone (lh), 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 CodeNGE  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-02
Decision Date1998-10-28

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