The following data is part of a premarket notification filed by Medica Corp. with the FDA for Medica Easylyte Sodium/potassium Analyzer.
| Device ID | K864872 |
| 510k Number | K864872 |
| Device Name: | MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Contact | Robert W Hagopian |
| Correspondent | Robert W Hagopian MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-12 |
| Decision Date | 1987-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100003289 | K864872 | 000 |
| 00386100002961 | K864872 | 000 |
| 00386100002978 | K864872 | 000 |
| 00386100002985 | K864872 | 000 |
| 00386100003029 | K864872 | 000 |
| 00386100003081 | K864872 | 000 |
| 00386100003173 | K864872 | 000 |
| 00386100003180 | K864872 | 000 |
| 00386100003197 | K864872 | 000 |
| 00386100003203 | K864872 | 000 |
| 00386100003210 | K864872 | 000 |
| 00386100003272 | K864872 | 000 |
| 00386100002862 | K864872 | 000 |