NORDICLAB ESTRADIOL RIA TEST

Radioimmunoassay, Estradiol

NORDICLAB INTL.

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

Pre-market Notification Details

Device IDK800920
510k NumberK800920
Device Name:NORDICLAB ESTRADIOL RIA TEST
ClassificationRadioimmunoassay, Estradiol
Applicant NORDICLAB INTL. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCHP  
CFR Regulation Number862.1260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-21
Decision Date1980-05-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.