K243070
- 510(k) number
- K243070
- Device name
- Xpert® SA Nasal Complete
- Applicant
- Cepheid® CA · US
- Product code
- NQX — System, Nucleic Acid Amplification Test, Dna, Methic
- Decision date
- 2024-10-25
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243070.pdf
Official FDA record: K243070
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.