The following data is part of a premarket notification filed by Sentinel Ch. Srl with the FDA for Modification To Sentinel Clin Chem Cal.
| Device ID | K070971 |
| 510k Number | K070971 |
| Device Name: | MODIFICATION TO SENTINEL CLIN CHEM CAL |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SENTINEL CH. SRL Via Robert Koch, 2 Milano, IT 20152 |
| Contact | Fabio Rota |
| Correspondent | Fabio Rota SENTINEL CH. SRL 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 | 2007-04-06 |
| Decision Date | 2007-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058056680136 | K070971 | 000 |