K234005
- 510(k) number
- K234005
- Device name
- Access CK-MB
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- JHX — Fluorometric Method, Cpk Or Isoenzymes
- Decision date
- 2024-02-16
- Date received
- 2023-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K234005.pdf
Official FDA record: K234005
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.