The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Ion 4 Sodium/potassium/chloride/total.
| Device ID | K842025 |
| 510k Number | K842025 |
| Device Name: | ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-18 |
| Decision Date | 1984-06-22 |