The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyelectrolyte Analyzer And Rapidlyte Analyzer.
| Device ID | K000926 |
| 510k Number | K000926 |
| Device Name: | EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER |
| Classification | Electrode, Ion-specific, Chloride |
| 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 | CGZ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-22 |
| Decision Date | 2000-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100002831 | K000926 | 000 |
| 00630414471112 | K000926 | 000 |
| 00630414452289 | K000926 | 000 |
| 00630414452142 | K000926 | 000 |
| 00630414452135 | K000926 | 000 |
| 00630414452104 | K000926 | 000 |
| 00630414452098 | K000926 | 000 |
| 00630414451893 | K000926 | 000 |
| 00630414451855 | K000926 | 000 |
| 00630414451848 | K000926 | 000 |
| 00630414484563 | K000926 | 000 |
| 00630414484587 | K000926 | 000 |
| 00386100001636 | K000926 | 000 |
| 00386100002817 | K000926 | 000 |
| 00386100002794 | K000926 | 000 |
| 00386100002695 | K000926 | 000 |
| 00386100002688 | K000926 | 000 |
| 00386100002541 | K000926 | 000 |
| 00386100002503 | K000926 | 000 |
| 00386100002473 | K000926 | 000 |
| 00386100001650 | K000926 | 000 |
| 00386100001643 | K000926 | 000 |
| 00630414451817 | K000926 | 000 |