LEECO E2 QUANT DIAG. TEST KIT

Radioimmunoassay, Estradiol

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco E2 Quant Diag. Test Kit.

Pre-market Notification Details

Device IDK834586
510k NumberK834586
Device Name:LEECO E2 QUANT DIAG. TEST KIT
ClassificationRadioimmunoassay, Estradiol
Applicant LEECO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCHP  
CFR Regulation Number862.1260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-29
Decision Date1984-03-09

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