Alere Afinion HbA1c and ACR on Afinion 2 analyzer
FDA 510(k) clearance K171650 · decided 2017-11-21
Clearance details
- K-number
- K171650
- Device name
- Alere Afinion HbA1c and ACR on Afinion 2 analyzer
- Applicant
- Abbott Rapid Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2017-06-05
- Decision date
- 2017-11-21
- Days to decision
- 169 days
- Clearance type
- Special
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT. recall (Z-1830-2025) | Mckesson Medical-Surgical Inc. Corporate Office | 2025-05-27 |
| Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. recall (Z-2736-2024) | Abbott Diagnostics Technologies AS | 2024-08-27 |