K181915 is an FDA 510(k) clearance for the PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Ixensor Co, Ltd. (Taipei City, TW). The FDA issued a Cleared decision on April 12, 2019, 269 days after receiving the submission on July 17, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K181915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2018 |
| Decision Date | April 12, 2019 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCP - Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |