The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easy Stat Sodium/potassium/lithium Analyzer.
| Device ID | K961326 |
| 510k Number | K961326 |
| Device Name: | EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Product Code | CEM |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIH |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-06-21 |