K232791
- 510(k) number
- K232791
- Device name
- Access Intact PTH
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- CEW — Radioimmunoassay, Parathyroid Hormone
- Decision date
- 2024-03-01
- Date received
- 2023-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232791.pdf
Official FDA record: K232791
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.