INVERNESS MEDICAL EARLY PREGNANCY TEST

Kit, Test, Pregnancy, Hcg, Over The Counter

SELFCARE, INC.

The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for Inverness Medical Early Pregnancy Test.

Pre-market Notification Details

Device IDK002049
510k NumberK002049
Device Name:INVERNESS MEDICAL EARLY PREGNANCY TEST
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant SELFCARE, INC. 200 PROSPECT ST. Waltham,  MA  02154 -3457
ContactCarol A Adiletto
CorrespondentCarol A Adiletto
SELFCARE, INC. 200 PROSPECT ST. Waltham,  MA  02154 -3457
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-03
Decision Date2000-07-27

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