The following data is part of a premarket notification filed by Ionetics, Inc. with the FDA for Miniature Ion Selective Electrodes.
| Device ID | K802856 |
| 510k Number | K802856 |
| Device Name: | MINIATURE ION SELECTIVE ELECTRODES |
| Classification | Electrode, Ion Specific, Calcium |
| Applicant | IONETICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JFP |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-12 |
| Decision Date | 1981-01-28 |