510(k) 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 by Chemtron Biotech, Inc. — Product Code DJG

K232736 is an FDA 510(k) premarket notification submitted by Chemtron Biotech, Inc. for the device "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". The FDA issued a decision of Substantially Equivalent on December 20, 2023. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Chemtron Biotech, Inc. has at least 10 other 510(k) clearances on record.