K180509 is an FDA 510(k) clearance for the Quo-Test A1c System. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Ekf Diagnostic GmbH (Barleben, DE). The FDA issued a Cleared decision on February 16, 2019, 354 days after receiving the submission on February 27, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K180509 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2018 |
| Decision Date | February 16, 2019 |
| Days to Decision | 354 days |
| Submission Type | Dual Track |
| 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 |