510(k) K132031
K132031 is an FDA 510(k) premarket notification submitted by Axis-Shield Poc AS for the device "AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL". The FDA issued a decision of Substantially Equivalent on March 21, 2014. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Axis-Shield Poc AS has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2014
- Date Received
- July 18, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Esterase--Oxidase, Cholesterol
- Device Class
- Class I
- Regulation Number
- 862.1175
- Review Panel
- CH
- Submission Type