The following data is part of a premarket notification filed by Sentinel Ch. Spa with the FDA for Multigent Creatinine (enzymatic) Assay.
| Device ID | K073634 |
| 510k Number | K073634 |
| Device Name: | MULTIGENT CREATININE (ENZYMATIC) ASSAY |
| Classification | Enzymatic Method, Creatinine |
| 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 | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-06-19 |
| Summary: | summary |