Chemtron Biotech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card TDecember 20, 2023
K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup wApril 18, 2016
K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000April 17, 2015
K142580Chemtrue Multi-Panel DOA DIP Card TestsDecember 1, 2014
K142396Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsOctober 9, 2014
K131931CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TESTJuly 26, 2013
K123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINEMay 30, 2013
K123080CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTSNovember 29, 2012
K121339CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTSMay 17, 2012
K111322CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARDSeptember 14, 2011
K102203CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTSJanuary 20, 2011