Cleared Dual Track

Cholestech LDX ? System

K223179 · Alere San Diego, Inc. · Chemistry

Sep 2023

Decision

344d

Days

Class 2

Risk

About This 510(k) Submission

K223179 is an FDA 510(k) clearance for the Cholestech LDX ? System, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Alere San Diego, Inc. (San Deigo, US). The FDA issued a Cleared decision on September 20, 2023, 344 days after receiving the submission on October 11, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K223179 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 2022
Decision Date	September 20, 2023
Days to Decision	344 days
Submission Type	Dual Track
Review Panel	Chemistry (CH)
Summary	Summary PDF