The following data is part of a premarket notification filed by Thermo Electron Oy with the FDA for Cystatin C Antiserum, Calibrator, Control And Control High.
| Device ID | K063647 |
| 510k Number | K063647 |
| Device Name: | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH |
| Classification | Test, Cystatin C |
| 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 | NDY |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-07 |
| Decision Date | 2007-03-12 |
| Summary: | summary |