The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easylyte Calcium/chloride Analyzer.
| Device ID | K963694 |
| 510k Number | K963694 |
| Device Name: | EASYLYTE CALCIUM/CHLORIDE ANALYZER |
| Classification | Electrode, Ion Specific, Calcium |
| 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 | JFP |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHL |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1996-11-27 |