The following data is part of a premarket notification filed by Thermo Electron Oy with the FDA for Hba1c; Calibrator; Control Normal, Control Abnormal.
| Device ID | K063209 |
| 510k Number | K063209 |
| Device Name: | HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | THERMO ELECTRON OY RATASTIE 2 Vantaa, FI 01620 |
| Contact | Paivi Sormunen |
| Correspondent | Paivi Sormunen THERMO ELECTRON OY RATASTIE 2 Vantaa, FI 01620 |
| Product Code | LCP |
| Subsequent Product Code | JJX |
| Subsequent Product Code | KRZ |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-23 |
| Decision Date | 2007-03-21 |