The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for Pantex Fte Free Testosterone Radioimmunoassay Kit.
| Device ID | K862483 |
| 510k Number | K862483 |
| Device Name: | PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Contact | Neil Chiamori |
| Correspondent | Neil Chiamori PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-30 |
| Decision Date | 1987-01-14 |