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KHE — Reagent, Occult Blood Class II

FDA Device Classification

Classification Details

Product Code
KHE
Device Class
Class II
Regulation Number
864.6550
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K173212alfa scientific designsInstant-view-PLUS immunochemical Fecal Occult Blood TestFebruary 15, 2018
K170548enterixInSure ONEOctober 5, 2017
K171484immunostics inchema-screen SPECIFIC GoldJune 14, 2017
K162333guangzhou wondfo biotech coWondfo One Step Fecal Occult Blood (FOB) TestMay 14, 2017
K163554immunostics inchema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestJanuary 17, 2017
K143325eiken chemical coOC-Light S FITAugust 20, 2015
K121397sekisui diagnosticsOSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 December 28, 2012
K113506ind diagnosticsIND ONE STEP OCCULT BLOOD (FOB) TESTDecember 19, 2012
K110309orient gene biotechFOB ONE STEP RAPID TESTSeptember 14, 2011
K102664immunostics incHEMA SCREEN ERJanuary 28, 2011
K100031ind diagnosticIND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10July 19, 2010
K100817princeton biomeditechBIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TESTJuly 1, 2010
K080812beckman coulterHEMOCCULT ICTJune 25, 2008
K071242ameritek usaDBEST ONE STEP OCCULT BLOOD TEST KITSMarch 6, 2008
K073431tianjin new bay bioresearch coFORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOJanuary 14, 2008
K070660alfa scientific designsINSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TESTJune 21, 2007
K063693new bay bioresearch co.FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TESTMay 11, 2007
K063673innovaconINNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICEMarch 5, 2007
K060953yd diagnosticsOCCULTECH FECAL OCCULT BLOOD RAPID TESTSeptember 18, 2006
K061065teco diagnosticsFECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL FJuly 14, 2006