510(k) K151809
K151809 is an FDA 510(k) premarket notification submitted by Alere Technologies AS for the device "Alere Afinion HbA1c, Alere Afinion AS100 Analyzer". The FDA issued a decision of Substantially Equivalent on September 25, 2015. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Alere Technologies AS has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2015
- Date Received
- July 2, 2015
- Clearance Type
- Special
- 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