Cholestech LDX System— 510(k) K223179

Name: FDA 510(k) clearance K223179
Creator: U.S. Food and Drug Administration
Published: 2023-09-20

Substantially Equivalent

Alere San Diego, Inc.

FDA 510(k) clearance K223179 for Cholestech LDX System, Substantially Equivalent on 2023-09-20. Applicant: Alere San Diego, Inc.. Device class: 2.

Clearance details

Applicant: Alere San Diego, Inc.
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2022-10-11
Decision date: 2023-09-20
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGA

view all

K252488 — ABL90 FLEX PLUS System2026-05-01
K210933 — YSI 2900C Biochemistry Analyzer2024-09-30
K220328 — EasyStat 3002024-07-26
K223755 — i-STAT G cartridge with the i-STAT 1 System2023-09-11
K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-07-28

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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