125I-TESTOSTERONE TEST SET

Radioimmunoassay, Testosterones And Dihydrotestosterone

WIEN LABORATORIES, INC.

The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for 125i-testosterone Test Set.

Pre-market Notification Details

Device IDK802728
510k NumberK802728
Device Name:125I-TESTOSTERONE TEST SET
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant WIEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-03
Decision Date1980-12-11

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