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) K232736

Name: FDA 510(k) clearance K232736
Creator: U.S. Food and Drug Administration
Published: 2023-12-20

Substantially Equivalent

Chemtron Biotech, Inc.

FDA 510(k) clearance K232736 for 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, Substantially Equivalent on 2023-12-20. Applicant: Chemtron Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Chemtron Biotech, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2023-09-07
Decision date: 2023-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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