510(k) Report

Devices descending from K020771

21 later devices reach Acon One Step Drug Screen Test Card through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121987Wondfo Amphetamine Urine Test Wondfo Barbiturates Urine Test Wondfo Benzodiazepines…Guangzhou Wondfo Biotech Co., Ltd.20120—
+1K121557Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine TestGuangzhou Wondfo Biotech Co., Ltd.20121—
+1K112071Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine Test Model…Guangzhou Wondfo Biotech Co., Ltd.20116—
+1K112236Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine TestGuangzhou Wondfo Biotech Co., Ltd.20110—
+1K112395Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine TestGuangzhou Wondfo Biotech Co., Ltd.20110—
+1K111560Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, Wondfo Benzodiazepines…Guangzhou Wondfo Biotech Co., Ltd.20110—
+1K110182Cannabinoids Urine TestGuangzhou Wondfo Biotech Co., Ltd.20110—
+1K102203Chemtrue Single / Multi Drug Screen Cassette / Dip Card TestsChemtron Biotech, Inc.20116—
+1K050024One Step Multiple Drugs of Abuse AssaysGuangzhou Wondfo Biotech Co., Ltd.20050—
+2K152495Wondfo Propoxyphene Urine TestGuangzhou Wondfo Biotech Co., Ltd.20150—
+2K142580Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc.20144—
+2K133968Wondfo Multi-Drug Urine Test Cup, PanelGuangzhou Wondfo Biotech Co., Ltd.201401
+2K130665Wondofo Multi-Drug Urine Test Cup / PanelGuangzhou Wondfo Biotech Co., Ltd.20134—
+2K121339Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette TestsChemtron Biotech, Inc.20125—
+3K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…Nantong Egens Biotech Co., Ltd.20150—
+3K151557EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine -…Nantong Egens Biotech Co., Ltd.20150—
+3K150602CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd.20151—
+3K142044CR3 Keyless Split Sample Cup Phencyclidien - MethylenedioxymethamphetamineGuangzhou Wondfo Biotech Co., Ltd.20141—
+3K141532CR3 Keyless Split Sample Cup Amphetamine-CocaineGuangzhou Wondfo Biotech Co., Ltd.20141—
+3K140089CR3 Keyless Split Sample Cup (Opi-Bzo)Guangzhou Wondfo Biotech Co., Ltd.20141—
+4K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd.20150—