LEECO LH-QUANT DIAGNOSTIC KIT

Radioimmunoassay, Luteinizing Hormone

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Lh-quant Diagnostic Kit.

Pre-market Notification Details

Device IDK810662
510k NumberK810662
Device Name:LEECO LH-QUANT DIAGNOSTIC KIT
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-11
Decision Date1981-03-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.