RIGHT-DAY URINARY LH (EIA)

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 Urinary Lh (eia).

Pre-market Notification Details

Device IDK860538
510k NumberK860538
Device Name:RIGHT-DAY URINARY LH (EIA)
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 Received1986-02-12
Decision Date1986-07-29

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