510(k) Report

Devices descending from K132812

6 later devices reach Ucp Multi-Drug Test Key Cups through their predicates, nearest generation first.

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