The following data is part of a premarket notification filed by Medicon Hellas S.a. with the FDA for Ferritin-latex, Models 1418-2070, 1418-0279.
| Device ID | K062746 |
| 510k Number | K062746 |
| Device Name: | FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | MEDICON HELLAS S.A. 5-7 MELITONA ST. Gerakas, Attiki, GR 15344 |
| Contact | George Psichas |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-14 |
| Decision Date | 2006-11-20 |
| Summary: | summary |