K043268 is an FDA 510(k) clearance for the SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2. This device is classified as a Uranyl Acetate/zinc Acetate, Sodium (Class II - Special Controls, product code CEI).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on February 15, 2005, 81 days after receiving the submission on November 26, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K043268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2004 |
| Decision Date | February 15, 2005 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CEI — Uranyl Acetate/zinc Acetate, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |