K242190
- 510(k) number
- K242190
- Device name
- Access Cortisol; DxC 500i Clinical Analyzer
- Applicant
- Beckman Coulter, Inc. CA · US
- Product code
- CGR — Radioimmunoassay, Cortisol
- Decision date
- 2025-03-05
- Date received
- 2024-07-25
- 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: K242190.pdf
Official FDA record: K242190
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.