510(k) K180296
K180296 is an FDA 510(k) premarket notification submitted by Alere Technologies AS for the device "Afinion HbA1c Dx". The FDA issued a decision of Substantially Equivalent on May 7, 2018. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Alere Technologies AS has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2018
- Date Received
- February 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobin A1c Test System
- Device Class
- Class II
- Regulation Number
- 862.1373
- Review Panel
- CH
- Submission Type
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.