The following data is part of a premarket notification filed by Medica Corporation with the FDA for Easylyte Na/k/cl/ca Analyzer.
| Device ID | K152327 |
| 510k Number | K152327 |
| Device Name: | EasyLyte Na/K/Cl/Ca Analyzer |
| Classification | Electrode, Ion Specific, Calcium |
| Applicant | Medica Corporation 5 Oak Park Drive Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris Medica Corporation 5 Oak Park Drive Bedford, MA 01730 |
| Product Code | JFP |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-18 |
| Decision Date | 2016-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100003128 | K152327 | 000 |
| 00386100002930 | K152327 | 000 |