AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)

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 Amerlite Tsh-30 Ultrasensitive Assay (lan.0010q/2010q).

Pre-market Notification Details

Device IDK952211
510k NumberK952211
Device Name:AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
ContactBradford M Spring
CorrespondentBradford M Spring
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 Received1995-05-11
Decision Date1995-07-14

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