K081533 is an FDA 510(k) clearance for the SENTINEL PLASMAPROTEINS CAL 3X. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on June 25, 2008, 23 days after receiving the submission on June 2, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K081533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2008 |
| Decision Date | June 25, 2008 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIX - Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |