RIGHT-DAY OVULATION HOME TEST

Radioimmunoassay, Luteinizing Hormone

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Right-day Ovulation Home Test.

Pre-market Notification Details

Device IDK861354
510k NumberK861354
Device Name:RIGHT-DAY OVULATION HOME TEST
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
ContactLee, Ph.d.
CorrespondentLee, Ph.d.
LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
Product CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-10
Decision Date1986-09-16

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