IMMO PHASE, THYROID HORMONE

Radioimmunoassay, Thyroid-stimulating Hormone

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Immo Phase, Thyroid Hormone.

Pre-market Notification Details

Device IDK781409
510k NumberK781409
Device Name:IMMO PHASE, THYROID HORMONE
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant CORNING MEDICAL & SCIENTIFIC 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 Received1978-08-14
Decision Date1978-09-27

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