The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Sodium Assay, Easyra Potassium Assay, Easyra Chloride Assay, Easyra Carbon Dioxide Assay Model Cat No. 5423 & 520.
| Device ID | K100829 |
| 510k Number | K100829 |
| Device Name: | EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 |
| 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 | KHS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-24 |
| Decision Date | 2011-01-14 |