K251579
- 510(k) number
- K251579
- Device name
- VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
- Applicant
- bioMerieux, Inc. MO · US
- Product code
- LON — System, Test, Automated, Antimicrobial Susceptibilit
- Decision date
- 2025-08-21
- Date received
- 2025-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251579.pdf
Official FDA record: K251579
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.