The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Auraflex Testosterone Calibrator Pack.
| Device ID | K951685 |
| 510k Number | K951685 |
| Device Name: | AURAFLEX TESTOSTERONE CALIBRATOR PACK |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | C. D Kafader, Ii |
| Correspondent | C. D Kafader, Ii ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-10 |
| Decision Date | 1995-11-14 |