The following data is part of a premarket notification filed by Thermo Electron Oy with the FDA for Transferrin, Specical Calibrator, Specitrol And Specitrol High Controls.
| Device ID | K063086 |
| 510k Number | K063086 |
| Device Name: | TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | THERMO ELECTRON OY RATASTIE 2 PO BOX 100 Vantaa, FI Fin-01621 |
| Contact | Paivi Sormunen |
| Correspondent | Paivi Sormunen THERMO ELECTRON OY RATASTIE 2 PO BOX 100 Vantaa, FI Fin-01621 |
| Product Code | DDG |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-10 |
| Decision Date | 2007-08-08 |