K853404 is an FDA 510(k) clearance for the QCA POTASSIUM TEST KIT. This device is classified as a Tetraphenyl Borate, Colorimetry, Potassium (Class II - Special Controls, product code CEJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on August 23, 1985, 11 days after receiving the submission on August 12, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K853404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1985 |
| Decision Date | August 23, 1985 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEJ — Tetraphenyl Borate, Colorimetry, Potassium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |