K142985 is an FDA 510(k) clearance for the UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 26, 2015, 133 days after receiving the submission on October 16, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K142985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2014 |
| Decision Date | February 26, 2015 |
| Days to Decision | 133 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |