The following data is part of a premarket notification filed by Thermo Electron Oy with the FDA for Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 And 3, Tdm Calibration Set B, Nortrol And Abtrol.
| Device ID | K063705 |
| 510k Number | K063705 |
| Device Name: | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL |
| Classification | Assay, Porphyrin, Spectrophotometry, Lithium |
| 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 | NDW |
| Subsequent Product Code | DKB |
| Subsequent Product Code | JIX |
| Subsequent Product Code | KLS |
| CFR Regulation Number | 862.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-13 |
| Decision Date | 2007-10-09 |
| Summary: | summary |