K141728 is an FDA 510(k) clearance for the ACE CALIBRATOR. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on July 28, 2014, 32 days after receiving the submission on June 26, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K141728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2014 |
| Decision Date | July 28, 2014 |
| Days to Decision | 32 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT - Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |