The following data is part of a premarket notification filed by Nichols Institute with the FDA for B2-microglobulin Radioimmunoassay.
| Device ID | K920300 |
| 510k Number | K920300 |
| Device Name: | B2-MICROGLOBULIN RADIOIMMUNOASSAY |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| 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 | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-22 |
| Decision Date | 1992-03-17 |