The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Auraflex(r) Estradiol.
| Device ID | K946199 |
| 510k Number | K946199 |
| Device Name: | AURAFLEX(R) ESTRADIOL |
| Classification | Radioimmunoassay, Estradiol |
| 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 | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-04-03 |