K232963
- 510(k) number
- K232963
- Device name
- VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
- Applicant
- bioMerieux, Inc. MO · US
- Product code
- NGZ — Susceptibility Test Plate, Antifungal
- Decision date
- 2024-06-07
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232963.pdf
Official FDA record: K232963
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.