K801676 is an FDA 510(k) clearance for the FERRIZYME FERRITIN ENZYME IMMUNOASSAY. This device is classified as a Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code DBF).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 20, 1980, 29 days after receiving the submission on July 22, 1980.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K801676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1980 |
| Decision Date | August 20, 1980 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DBF — Ferritin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |