Name: Predicase
Price: 199 USD

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.
Product code	DJG
Device class	Class II
Decision date	Dec 20, 2023
Decision	Substantially Equivalent
Regulation	862.3650

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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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

Everything you need for a 510(k) submission. Nothing you don't.