K232545
- 510(k) number
- K232545
- Device name
- The SensiTox B. anthracis Toxin Test
- Applicant
- First Light Diagnostics, Inc. MA · US
- Product code
- QUU — Simple In Vitro Diagnostic Device For The Detection
- Decision date
- 2023-11-20
- Date received
- 2023-08-22
- 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: K232545.pdf
Official FDA record: K232545
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.