K232736

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

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.