510(k) Report

Devices descending from K050394

3 later devices reach Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132630Wondfo Oxazepam Urine Test (Bzo 200) and Wondfo Methamphetamine Urine Test (Met 300)Guangzhou Wondfo Biotech Co., Ltd.20130—
+1K131754Wondfo Cocaine Urine Test (Coc 100), Wondfo Cannabinoids Urine Test (THC 40)Guangzhou Wondfo Biotech Co., Ltd.20130—
+1K131232Wondfo Methadone Urine Test (MTD 200), Wondofo Morphine Urine Test (Mop 100)Guangzhou Wondfo Biotech Co., Ltd.20130—