510(k) Report

Devices descending from K970357

4 later devices reach Episcreen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011057Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXXOraSure Technologies, Inc.20010—
+1K984361Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc.199911
+1K973395Episcreen Oral Specimen Collection DeviceEpitope, Inc.19982—
+2K991800Hemochek Urine Collection KitOsborn Group, Inc.19990—