EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)

Radioimmunoassay, Luteinizing Hormone

SELFCARE, INC.

The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for Early Ovulation Predictor (cassette), One Step Ovulation Predictor (cassette), Ovulation Predictor (cassette).

Pre-market Notification Details

Device IDK991466
510k NumberK991466
Device Name:EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant SELFCARE, INC. 200 PROSPECT ST. Waltham,  MA  02154 -3457
ContactCarol Adiletto
CorrespondentCarol Adiletto
SELFCARE, INC. 200 PROSPECT ST. Waltham,  MA  02154 -3457
Product CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-27
Decision Date1999-05-25
Summary:summary

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