The following data is part of a premarket notification filed by Sentinel Ch Spa with the FDA for Sentinel Lithium Assay.
| Device ID | K070987 |
| 510k Number | K070987 |
| Device Name: | SENTINEL LITHIUM ASSAY |
| Classification | Assay, Porphyrin, Spectrophotometry, Lithium |
| Applicant | SENTINEL CH SPA VIA ROBERT KOCH 2 Milan, IT 20152 |
| Contact | Fabio Rota |
| Correspondent | Fabio Rota SENTINEL CH SPA VIA ROBERT KOCH 2 Milan, IT 20152 |
| Product Code | NDW |
| CFR Regulation Number | 862.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-06 |
| Decision Date | 2007-08-02 |
| Summary: | summary |