510(k) Report

Devices descending from K110515

9 later devices reach Ucp Drug Screening Test Cups through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130463Ucp Home Drug Screening Test; Cards, CupsUcp Biosciences, Inc.20138—
+2K151213UCP Drug Test Mini CupsUcp Biosciences, Inc.20150—
+2K132812Ucp Multi-Drug Test Key CupsUcp Biosciences, Inc.20146—
+3K150791Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test…Healgen Scientific,, LLC20153—
+3K142609CR3 Keyless Split Sample Cup Nortriptyline-BuprenorphineGuangzhou Wondfo Biotech Co., Ltd.20141—
+4K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20170—
+4K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20160—
+4K151642Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20150—
+4K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd.20150—