The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Total T3 Chemiluminescence Assay.
| Device ID | K923015 |
| 510k Number | K923015 |
| Device Name: | TOTAL T3 CHEMILUMINESCENCE ASSAY |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Contact | Rramakirshnan |
| Correspondent | Rramakirshnan NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-22 |
| Decision Date | 1992-09-02 |