The following data is part of a premarket notification filed by Nichols Institute with the FDA for Allegro Lite Thyroid Stimulating Hormone Chem. Imm.
| Device ID | K903391 |
| 510k Number | K903391 |
| Device Name: | ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | NICHOLS INSTITUTE WORLDWAY POSTAL CENTER P.O. BOX 92797 Los Angeles, CA 90009 |
| Contact | Elaine Walton |
| Correspondent | Elaine Walton NICHOLS INSTITUTE WORLDWAY POSTAL CENTER P.O. BOX 92797 Los Angeles, CA 90009 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-27 |
| Decision Date | 1990-10-12 |