The following data is part of a premarket notification filed by Ionetics, Inc. with the FDA for Electrolyte Analyzer.
| Device ID | K851808 |
| 510k Number | K851808 |
| Device Name: | ELECTROLYTE ANALYZER |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | IONETICS, INC. 3020 ENTERPRISE Costa Mesa, CA 92626 |
| Contact | Kater |
| Correspondent | Kater IONETICS, INC. 3020 ENTERPRISE Costa Mesa, CA 92626 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-06-25 |