K214117
- 510(k) number
- K214117
- Device name
- Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
- Applicant
- Abbott Diagnostics Technologies AS NO
- Product code
- LCP — Assay, Glycosylated Hemoglobin
- Decision date
- 2023-09-27
- Date received
- 2021-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Hematology
510(k) Summary (official FDA PDF): K214117.pdf
Official FDA record: K214117
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.