The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Free Thyroxine(f T4) Method/technicon Immuno 1(r).
| Device ID | K930322 |
| 510k Number | K930322 |
| Device Name: | FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-22 |
| Decision Date | 1993-11-10 |