NORDICLAB PROGESTERONE RIA TEST

Radioimmunoassay, Progesterone

NORDICLAB INTL.

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

Pre-market Notification Details

Device IDK800922
510k NumberK800922
Device Name:NORDICLAB PROGESTERONE RIA TEST
ClassificationRadioimmunoassay, Progesterone
Applicant NORDICLAB INTL. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-21
Decision Date1980-05-14

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