The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Potassium Analyzer-sodium/electrolyte.
| Device ID | K830588 |
| 510k Number | K830588 |
| Device Name: | POTASSIUM ANALYZER-SODIUM/ELECTROLYTE |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | SHABAN MFG. CO. 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 | 1983-02-23 |
| Decision Date | 1983-04-27 |