K222638
- 510(k) number
- K222638
- Device name
- Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
- Applicant
- Cepheid CA · US
- Product code
- NJR — Nucleic Acid Amplification Assay System, Group B Str
- Decision date
- 2023-09-27
- Date received
- 2022-09-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K222638.pdf
Official FDA record: K222638
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.