510(k) Report

Devices descending from K151395

3 later devices reach Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.20191—
+1K182779ARK EDDP AssayArk Diagnostics, Inc.20180—
+2K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.20200—