DIRECT ESTRIOL RIA KIT

Radioimmunoassay, Estriol

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Direct Estriol Ria Kit.

Pre-market Notification Details

Device IDK781546
510k NumberK781546
Device Name:DIRECT ESTRIOL RIA KIT
ClassificationRadioimmunoassay, Estriol
Applicant Immunalysis Corporation 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGI  
CFR Regulation Number862.1265 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-13
Decision Date1978-12-04

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