The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Allegro (tm) Ferritin Immunoassay System.
| Device ID | K874572 |
| 510k Number | K874572 |
| Device Name: | ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM |
| Classification | Ferritin, Antigen, Antiserum, Control |
| 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 | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-05 |
| Decision Date | 1987-12-02 |