510(k) Report

Devices descending from K021423

3 later devices reach Instant-View Fecal Occult Blood Rapid Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.20180—
+1K121397Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test KitSEKISUI Diagnostics, LLC20120—
+1K060953Occultech Fecal Occult Blood Rapid TestYd Diagnostics Corp.20060—