The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easylyte Na/k/cl/li Analyzer, Model 2020.
| Device ID | K100673 |
| 510k Number | K100673 |
| Device Name: | EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JIH |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-09 |
| Decision Date | 2010-04-06 |