K233480
- 510(k) number
- K233480
- Device name
- Access SHBG
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- CDZ — Radioimmunoassay, Testosterones And Dihydrotestoster
- Decision date
- 2024-02-08
- Date received
- 2023-10-26
- 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: K233480.pdf
Official FDA record: K233480
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.