K900300 is an FDA 510(k) clearance for the LYTENING 2Z LYTENING SYSTEM 31. This device is classified as a Electrode, Ion Specific, Potassium (Class II - Special Controls, product code CEM).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 1, 1990, 38 days after receiving the submission on January 22, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K900300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1990 |
| Decision Date | March 01, 1990 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEM — Electrode, Ion Specific, Potassium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |