The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Testosterone Direct Radioimmunoassay.
Device ID | K841948 |
510k Number | K841948 |
Device Name: | TESTOSTERONE DIRECT RADIOIMMUNOASSAY |
Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
Applicant | SORIN BIOMEDICA, FIAT, USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDZ |
CFR Regulation Number | 862.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-14 |
Decision Date | 1984-06-25 |