The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Allegro Ige Enzyme Immunoassay System.
| Device ID | K860851 |
| 510k Number | K860851 |
| Device Name: | ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM |
| Classification | Ige, Peroxidase, 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 | DGO |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-07 |
| Decision Date | 1986-03-28 |