K231381
- 510(k) number
- K231381
- Device name
- Xpert Xpress MVP; GeneXpert Xpress System
- Applicant
- Cepheid CA · US
- Product code
- PQA — Vaginitis And Bacterial Vaginosis Nucleic Acid Detec
- Decision date
- 2023-10-19
- Date received
- 2023-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K231381.pdf
Official FDA record: K231381
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.