510(k) K120615— ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE

Substantially Equivalent

Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen

Clearance details

Applicant: Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2012-02-29
Decision date: 2013-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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.