K152327 is an FDA 510(k) clearance for the EasyLyte Na/K/Cl/Ca Analyzer. This device is classified as a Electrode, Ion Specific, Calcium (Class II - Special Controls, product code JFP).
Submitted by Medica Corporation (Bedford, US). The FDA issued a Cleared decision on December 1, 2016, 471 days after receiving the submission on August 18, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K152327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2015 |
| Decision Date | December 01, 2016 |
| Days to Decision | 471 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JFP - Electrode, Ion Specific, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |