NORDICLAB TOTAL ESTRIOL RIA TEST

Radioimmunoassay, Estriol

NORDICLAB INTL.

The following data is part of a premarket notification filed by Nordiclab Intl. with the FDA for Nordiclab Total Estriol Ria Test.

Pre-market Notification Details

Device IDK792189
510k NumberK792189
Device Name:NORDICLAB TOTAL ESTRIOL RIA TEST
ClassificationRadioimmunoassay, Estriol
Applicant NORDICLAB INTL. 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 Received1979-10-31
Decision Date1979-11-13

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