The following data is part of a premarket notification filed by Sentinel Ch. Spa with the FDA for Sentinel Plasmaproteins Cal 3x.
| Device ID | K081533 |
| 510k Number | K081533 |
| Device Name: | SENTINEL PLASMAPROTEINS CAL 3X |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SENTINEL CH. SpA Via Robert Koch, 2 Milano, IT 20152 |
| Contact | Fabio Rota |
| Correspondent | Fabio Rota SENTINEL CH. SpA Via Robert Koch, 2 Milano, IT 20152 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2008-06-25 |
| Summary: | summary |