The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyelectrolyte Na/k/li Analyzer & Rapidlyte Na/k/li Analyzer.
| Device ID | K002407 |
| 510k Number | K002407 |
| Device Name: | EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI 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 | JIH |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2001-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100003524 | K002407 | 000 |
| 00386100002558 | K002407 | 000 |
| 00386100002480 | K002407 | 000 |
| 00386100001667 | K002407 | 000 |
| 00630414451862 | K002407 | 000 |
| 00630414451824 | K002407 | 000 |