K231927
- 510(k) number
- K231927
- Device name
- Elecsys PTH , Elecsys PTH STAT
- Applicant
- Roche Diagnostics IN · US
- Product code
- CEW — Radioimmunoassay, Parathyroid Hormone
- Decision date
- 2024-03-22
- Date received
- 2023-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231927.pdf
Official FDA record: K231927
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.