AMERLITE FSH ASSAY

Radioimmunoassay, Follicle-stimulating Hormone

JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Amerlite Fsh Assay.

Pre-market Notification Details

Device IDK952285
510k NumberK952285
Device Name:AMERLITE FSH ASSAY
ClassificationRadioimmunoassay, Follicle-stimulating Hormone
Applicant JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
ContactYvonne E Middlefell
CorrespondentYvonne E Middlefell
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
Product CodeCGJ  
CFR Regulation Number862.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-16
Decision Date1995-07-03

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