LEE-BEAD BETA FSH (EIA)

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 Lee-bead Beta Fsh (eia).

Pre-market Notification Details

Device IDK854837
510k NumberK854837
Device Name:LEE-BEAD BETA FSH (EIA)
ClassificationRadioimmunoassay, Follicle-stimulating Hormone
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 CodeCGJ  
CFR Regulation Number862.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-03
Decision Date1986-01-13

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