K043267 is an FDA 510(k) clearance for the POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2. This device is classified as a Tetraphenyl Borate, Colorimetry, Potassium (Class II - Special Controls, product code CEJ).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on February 10, 2005, 76 days after receiving the submission on November 26, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K043267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2004 |
| Decision Date | February 10, 2005 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CEJ — Tetraphenyl Borate, Colorimetry, Potassium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |