K214117 is an FDA 510(k) clearance for the Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Abbott Diagnostics Technologies AS (Oslo, NO). The FDA issued a Cleared decision on September 27, 2023, 636 days after receiving the submission on December 30, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K214117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2021 |
| Decision Date | September 27, 2023 |
| Days to Decision | 636 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 |