K881440 is an FDA 510(k) clearance for the IQ POTASSIUM. 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 (Franklin Lakes, US). The FDA issued a Cleared decision on May 27, 1988, 52 days after receiving the submission on April 5, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K881440 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1988 |
| Decision Date | May 27, 1988 |
| Days to Decision | 52 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 |