K240797
- 510(k) number
- K240797
- Device name
- PPH Saliva Collection Kit
- Applicant
- Permantis Public Health NY · US
- Product code
- QBD — Microbial Nucleic Acid Storage And Stabilization Dev
- Decision date
- 2024-10-11
- Date received
- 2024-03-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240797.pdf
Official FDA record: K240797
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.