The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Allegro Tm Hs-tsh Immunoassay System.
| Device ID | K853717 |
| 510k Number | K853717 |
| Device Name: | ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 26441 VIA DE ANZA San Juan Capistrano, CA 92675 |
| Contact | Elaine Walton |
| Correspondent | Elaine Walton NICHOLS INSTITUTE DIAGNOSTICS 26441 VIA DE ANZA San Juan Capistrano, CA 92675 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-05 |
| Decision Date | 1985-10-02 |