510(k) K050574
K050574 is an FDA 510(k) premarket notification submitted by Axis-Shield Poc AS for the device "AFINION HBALC". The FDA issued a decision of Substantially Equivalent on July 22, 2005. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Axis-Shield Poc AS has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2005
- Date Received
- March 7, 2005
- Clearance Type
- Traditional
- 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