LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT

Radioimmunoassay, Progesterone

LEECO DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK850056
510k NumberK850056
Device Name:LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT
ClassificationRadioimmunoassay, Progesterone
Applicant LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
ContactJames P Lee
CorrespondentJames P Lee
LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-08
Decision Date1985-02-06

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