The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easylyte Sodium/potassium/chloride Analyzer.
| Device ID | K895936 |
| 510k Number | K895936 |
| Device Name: | EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Contact | Howard Guthermann |
| Correspondent | Howard Guthermann MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-11 |
| Decision Date | 1989-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100003098 | K895936 | 000 |
| 00386100003050 | K895936 | 000 |
| 00386100003043 | K895936 | 000 |
| 00386100002879 | K895936 | 000 |