NEONATAL NTSH RADIOIMMUNOASSAY SYS

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 Neonatal Ntsh Radioimmunoassay Sys.

Pre-market Notification Details

Device IDK830036
510k NumberK830036
Device Name:NEONATAL NTSH RADIOIMMUNOASSAY SYS
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 Received1983-01-07
Decision Date1983-01-28

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