510(k) Report

Devices descending from K880499

7 later devices reach Hemoccult Sensitive Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070660Instant-View Fecal Occult Blood (Fob) Rapid TestAlfa Scientific Designs, Inc.20073—
+1K021423Instant-View Fecal Occult Blood Rapid TestAlfa Scientific Designs, Inc.20023—
+2K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.20180—
+2K121397Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test KitSEKISUI Diagnostics, LLC20120—
+2K110309Fob One Step Rapid TestOrient Gene Biotech20111—
+2K060953Occultech Fecal Occult Blood Rapid TestYd Diagnostics Corp.20060—
+3K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd.20170—