510(k) Report

Devices descending from K130463

8 later devices reach Ucp Home Drug Screening Test; Cards, Cups through their predicates, nearest generation first.

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