AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL— 510(k) K132031

Name: FDA 510(k) clearance K132031
Creator: U.S. Food and Drug Administration
Published: 2014-03-21

Substantially Equivalent

Axis-Shield Poc AS

FDA 510(k) clearance K132031 for AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL, Substantially Equivalent on 2014-03-21. Applicant: Axis-Shield Poc AS. Device class: 1.

Clearance details

Applicant: Axis-Shield Poc AS
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2013-07-18
Decision date: 2014-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oslo, NO

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHH

view all

K251091 — Lipids2025-12-30
K232404 — CHOLESTEROL; HDL-cholesterol; LDL-cholesterol; TRIGLYCERIDES2024-08-09
K203597 — Cholesterol22022-06-30
K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides2019-03-27
K181373 — Extended Lipid Panel Assay2018-10-18

More clearances from Axis-Shield Poc AS

view all

K110056 — AFINION ANALYZER2011-02-15
K072409 — AFINION ACR AND ACR CONTROL2008-02-12
K050574 — AFINION HBALC2005-07-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.