The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Imx T3 Assay.
| Device ID | K944808 |
| 510k Number | K944808 |
| Device Name: | IMX T3 ASSAY |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | C D Kafader Iii |
| Correspondent | C D Kafader Iii ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-29 |
| Decision Date | 1994-12-09 |