The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easylyte Sodium/potassium/chloride/lithium Analyzer.
| Device ID | K963763 |
| 510k Number | K963763 |
| Device Name: | EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER |
| Classification | Electrode, Ion Specific, Sodium |
| 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 | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JIH |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-19 |
| Decision Date | 1996-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100002923 | K963763 | 000 |
| 00386100002916 | K963763 | 000 |
| 00386100002909 | K963763 | 000 |