K162275 is an FDA 510(k) clearance for the Randox RX Daytona Plus Alkaline Phosphatase (ALP). This device is classified as a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II - Special Controls, product code CJE).
Submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on April 21, 2017, 252 days after receiving the submission on August 12, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K162275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2016 |
| Decision Date | April 21, 2017 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJE - Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |