K142362 is an FDA 510(k) clearance for the Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.. This device is classified as a System, Test, Vitamin D (Class II - Special Controls, product code MRG).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 19, 2014, 116 days after receiving the submission on August 25, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K142362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2014 |
| Decision Date | December 19, 2014 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MRG — System, Test, Vitamin D |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1825 |