K231465 is an FDA 510(k) clearance for the Q-Pad Test System. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Qurasense (Menlo Park, US). The FDA issued a Cleared decision on December 6, 2023, 201 days after receiving the submission on May 19, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K231465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2023 |
| Decision Date | December 06, 2023 |
| Days to Decision | 201 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 |