K223179
- 510(k) number
- K223179
- Device name
- Cholestech LDX System
- Applicant
- Alere San Diego, Inc. CA · US
- Product code
- CGA — Glucose Oxidase, Glucose
- Decision date
- 2023-09-20
- Date received
- 2022-10-11
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K223179.pdf
Official FDA record: K223179
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.