LEECO FSH-QUANT DIAGNOSTIC KIT

Radioimmunoassay, Follicle-stimulating Hormone

LEECO DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK810663
510k NumberK810663
Device Name:LEECO FSH-QUANT DIAGNOSTIC KIT
ClassificationRadioimmunoassay, Follicle-stimulating Hormone
Applicant LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGJ  
CFR Regulation Number862.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-11
Decision Date1981-03-27

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