K183230 is an FDA 510(k) clearance for the OneDraw A1C Test System. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Drawbridge Health, Inc. (San Diego, US). The FDA issued a Cleared decision on August 15, 2019, 268 days after receiving the submission on November 20, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K183230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2018 |
| Decision Date | August 15, 2019 |
| Days to Decision | 268 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 |