K162200 is an FDA 510(k) clearance for the Randox RX Daytona Plus Magnesium (MG). This device is classified as a Photometric Method, Magnesium (Class I - General Controls, product code JGJ).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on April 28, 2017, 266 days after receiving the submission on August 5, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K162200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2016 |
| Decision Date | April 28, 2017 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JGJ — Photometric Method, Magnesium |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1495 |