510(k) K214117
K214117 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics Technologies AS for the device "Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer". The FDA issued a decision of Substantially Equivalent on September 27, 2023. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2023
- Date Received
- December 30, 2021
- Clearance Type
- Dual Track
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Glycosylated Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7470
- Review Panel
- HE
- Submission Type