INVERNESS MEDICAL EARLY PREGNANCY TEST

Kit, Test, Pregnancy, Hcg, Over The Counter

CAMBRIDGE DIAGNOSTICS IRELAND, LTD.

The following data is part of a premarket notification filed by Cambridge Diagnostics Ireland, Ltd. with the FDA for Inverness Medical Early Pregnancy Test.

Pre-market Notification Details

Device IDK013907
510k NumberK013907
Device Name:INVERNESS MEDICAL EARLY PREGNANCY TEST
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant CAMBRIDGE DIAGNOSTICS IRELAND, LTD. MERVUE BUSINESS PARK Galway,  IE
ContactAvril Murray
CorrespondentAvril Murray
CAMBRIDGE DIAGNOSTICS IRELAND, LTD. MERVUE BUSINESS PARK Galway,  IE
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-11-26
Decision Date2001-12-18
Summary:summary

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