K882822 is an FDA 510(k) clearance for the FIAGEN FERRITIN. This device is classified as a Igm, Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code DFL).
Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on August 4, 1988, 27 days after receiving the submission on July 8, 1988.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K882822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 1988 |
| Decision Date | August 04, 1988 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DFL — Igm, Ferritin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |