K232164
- 510(k) number
- K232164
- Device name
- Access NT-proBNP
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- NBC — Test, Natriuretic Peptide
- Decision date
- 2024-04-12
- Date received
- 2023-07-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232164.pdf
Official FDA record: K232164
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.