VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)

Radioimmunoassay, Thyroid-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 Vitros Immunodiagnostics Products/tsh Reagent Pack (gem. 1001)/tsh Calibrators(gem.c001).

Pre-market Notification Details

Device IDK964558
510k NumberK964558
Device Name:VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
ContactAnn M Quinn
CorrespondentAnn M Quinn
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-13
Decision Date1996-12-16

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