The following data is part of a premarket notification filed by Ionetics, Inc. with the FDA for Calcium And Ph Electrolyte Analyzer.
| Device ID | K895397 |
| 510k Number | K895397 |
| Device Name: | CALCIUM AND PH ELECTROLYTE ANALYZER |
| Classification | Electrode, Ion Specific, Calcium |
| Applicant | IONETICS, INC. 3020 ENTERPRISE Costa Mesa, CA 92626 |
| Contact | John Kater |
| Correspondent | John Kater IONETICS, INC. 3020 ENTERPRISE Costa Mesa, CA 92626 |
| Product Code | JFP |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-01 |
| Decision Date | 1989-12-12 |