Cleared Traditional

AXINON? LDL-p Test System

K210801 · Numares AG · Chemistry

Jul 2023

Decision

854d

Days

Class 1

Risk

About This 510(k) Submission

K210801 is an FDA 510(k) clearance for the AXINON? LDL-p Test System, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Numares AG (Regensburg, DE). The FDA issued a Cleared decision on July 19, 2023, 854 days after receiving the submission on March 17, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K210801 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2021
Decision Date	July 19, 2023
Days to Decision	854 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF