The following data is part of a premarket notification filed by Thermo Electron Oy with the FDA for Lipoprotein(a), Lipoprotein(a) Calibrator, Lipoprotein (a) Control, Control High.
| Device ID | K063838 |
| 510k Number | K063838 |
| Device Name: | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| 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 | DFC |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-09-27 |