NORDICLAB TESTOSTERONE RIA TEST

Radioimmunoassay, Testosterones And Dihydrotestosterone

NORDICLAB INTL.

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

Pre-market Notification Details

Device IDK800921
510k NumberK800921
Device Name:NORDICLAB TESTOSTERONE RIA TEST
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant NORDICLAB INTL. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-21
Decision Date1980-05-14

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