K240698

Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard

510(k) number
K240698
Device name
Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
Applicant
Guangzhou Decheng Biotechnology Co., Ltd. CN
Product code
DJG — Enzyme Immunoassay, Opiates
Decision date
2024-05-10
Date received
2024-03-14
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K240698.pdf

Official FDA record: K240698
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.