TESTOSTERONE DIRECT RADIOIMMUNOASSAY

Radioimmunoassay, Testosterones And Dihydrotestosterone

SORIN BIOMEDICA, FIAT, USA, INC.

The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Testosterone Direct Radioimmunoassay.

Pre-market Notification Details

Device IDK841948
510k NumberK841948
Device Name:TESTOSTERONE DIRECT RADIOIMMUNOASSAY
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant SORIN BIOMEDICA, FIAT, USA, 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 Received1984-05-14
Decision Date1984-06-25

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