The following data is part of a premarket notification filed by Sentinel Ch. Spa with the FDA for Ckmb Udr Assay.
| Device ID | K102706 |
| 510k Number | K102706 |
| Device Name: | CKMB UDR ASSAY |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| 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 | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-20 |
| Decision Date | 2011-08-19 |
| Summary: | summary |