The following data is part of a premarket notification filed by Thermo Electron Oy with the FDA for Phenobarbital, Phenytoin, Tdm Calibration Set B And Abtrol/nortrol Controls.
| Device ID | K063145 |
| 510k Number | K063145 |
| Device Name: | PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| 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 | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-16 |
| Decision Date | 2007-10-17 |
| Summary: | summary |