The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for Pantex Direct Testosterone Coated Tube Radioimmuno.
| Device ID | K853865 |
| 510k Number | K853865 |
| Device Name: | PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Contact | Neil Y Chiamori |
| Correspondent | Neil Y 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 | 1985-09-17 |
| Decision Date | 1985-10-15 |