K232904
- 510(k) number
- K232904
- Device name
- Access Ostase
- Applicant
- Beckman Coulter MN · US
- Product code
- CIN — Electrophoretic Separation, Alkaline Phosphatase Iso
- Decision date
- 2024-04-15
- Date received
- 2023-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232904.pdf
Official FDA record: K232904
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.