K040879 is an FDA 510(k) clearance for the QUANTEX FERRITIN. This device is classified as a Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code DBF).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on May 10, 2004, 35 days after receiving the submission on April 5, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K040879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2004 |
| Decision Date | May 10, 2004 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DBF — Ferritin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |