K232736
- 510(k) number
- K232736
- Device name
- Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test
- Applicant
- Chemtron Biotech, Inc. CA · US
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2023-12-20
- Date received
- 2023-09-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K232736.pdf
Official FDA record: K232736
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.