K231013
- 510(k) number
- K231013
- Device name
- DNA/RNA Shield SafeCollect Saliva Collection kit
- Applicant
- Zymo Research CA · US
- Product code
- QBD — Microbial Nucleic Acid Storage And Stabilization Dev
- Decision date
- 2023-09-28
- Date received
- 2023-04-10
- 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: K231013.pdf
Official FDA record: K231013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.