K233060
- 510(k) number
- K233060
- Device name
- Elecsys Folate III
- Applicant
- Roche Diagnostics IN · US
- Product code
- CGN — Acid, Folic, Radioimmunoassay
- Decision date
- 2024-06-17
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K233060.pdf
Official FDA record: K233060
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.