The following data is part of a premarket notification filed by Immunotech S.a. with the FDA for Ft4 Radioimmunoassay.
| Device ID | K934012 |
| 510k Number | K934012 |
| Device Name: | FT4 RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | IMMUNOTECH S.A. 13276 MARSILLE CEDEX 9 France, FR |
| Contact | P. Prince |
| Correspondent | P. Prince IMMUNOTECH S.A. 13276 MARSILLE CEDEX 9 France, FR |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-18 |
| Decision Date | 1993-11-16 |