The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Knai Sodium Potassium Analyzer.
| Device ID | K830805 |
| 510k Number | K830805 |
| Device Name: | KNAI SODIUM POTASSIUM ANALYZER |
| Classification | Culture Media, Non-selective And Non-differential |
| Applicant | RADIOMETER AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSG |
| CFR Regulation Number | 866.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-14 |
| Decision Date | 1983-04-08 |