K231832
- 510(k) number
- K231832
- Device name
- Access Myoglobin
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- DDR — Myoglobin, Antigen, Antiserum, Control
- Decision date
- 2023-09-18
- Date received
- 2023-06-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231832.pdf
Official FDA record: K231832
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.