K062746 is an FDA 510(k) clearance for the FERRITIN-LATEX, MODELS 1418-2070, 1418-0279. This device is classified as a Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code DBF).
Submitted by Medicon Hellas S.A (Gerakas, Attiki, GR). The FDA issued a Cleared decision on November 20, 2006, 67 days after receiving the submission on September 14, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K062746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2006 |
| Decision Date | November 20, 2006 |
| Days to Decision | 67 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 |