The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Chemiluminescence Ferritin Immunoassay.
| Device ID | K984186 |
| 510k Number | K984186 |
| Device Name: | NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Contact | Jimmy Wong |
| Correspondent | Jimmy Wong NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-23 |
| Decision Date | 1999-02-02 |
| Summary: | summary |