K232898
- 510(k) number
- K232898
- Device name
- Quantisal Oral Fluid Collection Device
- Applicant
- Immunalysis Corporation CA · US
- Product code
- PJD — Oral Fluid Drugs Of Abuse And Alcohol Test Specimen
- Decision date
- 2023-11-21
- Date received
- 2023-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232898.pdf
Official FDA record: K232898
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.