THYROID STIMULATING HORMONE

Radioimmunoassay, Thyroid-stimulating Hormone

NEW ENGLAND NUCLEAR

The following data is part of a premarket notification filed by New England Nuclear with the FDA for Thyroid Stimulating Hormone.

Pre-market Notification Details

Device IDK771590
510k NumberK771590
Device Name:THYROID STIMULATING HORMONE
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-08-19
Decision Date1977-09-15

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