The following data is part of a premarket notification filed by Thermo Electron Oy with the FDA for Complement C3 And C4, Specical Calibrator And Specitrol Control And High Control.
| Device ID | K063150 |
| 510k Number | K063150 |
| Device Name: | COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL |
| Classification | Complement C3, 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 | CZW |
| Subsequent Product Code | DBI |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-16 |
| Decision Date | 2007-03-19 |
| Summary: | summary |