510(k) Report

Devices descending from K012745

5 later devices reach Triage Tox Drug Screen, Catalog #94000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043242Triage Tox Drug ScreenBiosite Incorporated200541
+2K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.20191—
+2K080347Uniscan -Doa SystemTaiwan Unison Biotech, Inc.20080—
+2K060791Triage Tox Drug Screen, Model 94400Biosite Incorporated200605
+3K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.20200—