The following data is part of a premarket notification filed by Nichols Institute with the FDA for Chemiluminescence Free T3 Immunoassay.
| Device ID | K931600 |
| 510k Number | K931600 |
| Device Name: | CHEMILUMINESCENCE FREE T3 IMMUNOASSAY |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 |
| Contact | Salvadore Palomares |
| Correspondent | Salvadore Palomares NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-01 |
| Decision Date | 1993-09-08 |