LEE-BEAD PROLACTIN (EIA)

Radioimmunoassay, Prolactin (lactogen)

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Lee-bead Prolactin (eia).

Pre-market Notification Details

Device IDK861945
510k NumberK861945
Device Name:LEE-BEAD PROLACTIN (EIA)
ClassificationRadioimmunoassay, Prolactin (lactogen)
Applicant LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
ContactLee, Ph.d.
CorrespondentLee, Ph.d.
LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
Product CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-20
Decision Date1986-06-13

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