K200865 is an FDA 510(k) clearance for the Piccolo Potassium Test System. This device is classified as a Test, System, Potassium, Enzymatic Method (Class II - Special Controls, product code MZV).
Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on October 20, 2021, 567 days after receiving the submission on April 1, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K200865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2020 |
| Decision Date | October 20, 2021 |
| Days to Decision | 567 days |
| Submission Type | Dual Track |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MZV — Test, System, Potassium, Enzymatic Method |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |