The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Aura Flex Ft4 200 Test Pack, Ft4 Calibrator Pack.
| Device ID | K944697 |
| 510k Number | K944697 |
| Device Name: | AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | ORGANON TEKNIKA CORP. TREYBURN 100 AKZO AVE. Durham, NC 27704 |
| Contact | C D Kafader Ii |
| Correspondent | C D Kafader Ii ORGANON TEKNIKA CORP. TREYBURN 100 AKZO AVE. Durham, NC 27704 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-23 |
| Decision Date | 1995-02-22 |