The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Allegro Intact Parathyroid Hormone Immunoassay.
| Device ID | K861797 |
| 510k Number | K861797 |
| Device Name: | ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS P.O. BOX 92797 Los Angeles, CA 90009 |
| Contact | Elaine Walton |
| Correspondent | Elaine Walton NICHOLS INSTITUTE DIAGNOSTICS P.O. BOX 92797 Los Angeles, CA 90009 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-09 |
| Decision Date | 1986-07-22 |