510(k) Report

Devices descending from K182123

11 later devices reach ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit…Hangzhou Laihe Biotech Co., Ltd.20240—
+1K232597LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi-Drug Test Kit (Cassette)…Hangzhou Laihe Biotech Co., Ltd.20240—
+1K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsAssure Tech. (Hangzhou) Co, Ltd.20218—
+2K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupGuangzhou Decheng Biotechnology Co., Ltd.20236—
+2K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup RxShenzhen Bioeasy Biotechnology Co., Ltd.20230—
+3K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.20250—
+3K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardGuangzhou Decheng Biotechnology Co., Ltd.20240—
+3K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC20243—
+4K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC20250—
+4K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.20250—
+4K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…Healgen Scientific,, LLC20240—