K811310 is an FDA 510(k) clearance for the SODIUM/POTASSIUM REAGENT KITS. This device is classified as a Electrode, Ion Specific, Potassium (Class II - Special Controls, product code CEM).
Submitted by Chem-Elec, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981, 60 days after receiving the submission on May 11, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K811310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1981 |
| Decision Date | July 10, 1981 |
| Days to Decision | 60 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 |