510(k) Report

Devices descending from K111322

6 later devices reach Chemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142580Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc.20144—
+1K123080Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsChemtron Biotech, Inc.20125—
+2K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…Nantong Egens Biotech Co., Ltd.20150—
+2K151557EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine -…Nantong Egens Biotech Co., Ltd.20150—
+2K150602CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd.20151—
+3K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd.20150—