K234012
- 510(k) number
- K234012
- Device name
- VITEK COMPACT PRO
- Applicant
- bioMerieux, Inc. MO · US
- Product code
- LON — System, Test, Automated, Antimicrobial Susceptibilit
- Decision date
- 2025-03-14
- Date received
- 2023-12-19
- 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: K234012.pdf
Official FDA record: K234012
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.