KHE · Class II · 21 CFR 864.6550

FDA Product Code KHE: Reagent, Occult Blood

Leading manufacturers include Helena Laboratories, Immunostics Inc., and Smithkline Diagnostics, Inc..

97
Total
97
Cleared
135d
Avg days
1976
Since

FDA 510(k) Cleared Reagent, Occult Blood Devices (Product Code KHE)

97 devices
1–24 of 97
Cleared Feb 15, 2018
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212
Alfa Scientific Designs, Inc.
Hematology · 136d
Cleared Oct 05, 2017
InSure ONE
K170548
Enterix, Inc.
Hematology · 223d
Cleared Jun 14, 2017
hema-screen SPECIFIC Gold
K171484
Immunostics Inc.,
Hematology · 23d
Cleared May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333
Guangzhou Wondfo Biotech Co., Ltd.
Hematology · 265d
Cleared Jan 17, 2017
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
K163554
Immunostics Inc.,
Hematology · 29d
Cleared Aug 20, 2015
OC-Light S FIT
K143325
Eiken Chemical Co., Ltd.
Hematology · 273d
Cleared Dec 28, 2012
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
K121397
SEKISUI Diagnostics, LLC
Hematology · 233d
Cleared Dec 19, 2012
IND ONE STEP OCCULT BLOOD (FOB) TEST
K113506
Ind Diagnostics, Inc.
Hematology · 387d
Cleared Sep 14, 2011
FOB ONE STEP RAPID TEST
K110309
Orient Gene Biotech
Hematology · 224d
Cleared Jan 28, 2011
HEMA SCREEN ER
K102664
Immunostics Inc.,
Hematology · 135d
Cleared Jul 19, 2010
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
K100031
Ind Diagnostic, Inc.
Hematology · 194d
Cleared Jul 01, 2010
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K100817
Princeton BioMeditech Corp.
Hematology · 104d
Cleared Jun 25, 2008
HEMOCCULT ICT
K080812
Beckman Coulter, Inc.
Hematology · 93d
Cleared Mar 06, 2008
DBEST ONE STEP OCCULT BLOOD TEST KITS
K071242
Ameritek USA, Inc.
Hematology · 308d
Cleared Jan 14, 2008
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE)
K073431
Tianjin New Bay Bioresearch Co., Ltd.
Hematology · 39d
Cleared Jun 21, 2007
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660
Alfa Scientific Designs, Inc.
Hematology · 104d
Cleared May 11, 2007
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
K063693
New Bay Bioresearch Co. , Ltd.
Hematology · 149d
Cleared Mar 05, 2007
INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
K063673
Innovacon, Inc.
Hematology · 84d
Cleared Sep 18, 2006
OCCULTECH FECAL OCCULT BLOOD RAPID TEST
K060953
Yd Diagnostics Corp.
Hematology · 165d
Cleared Jul 14, 2006
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
K061065
Teco Diagnostics
Hematology · 88d
Cleared Jun 06, 2006
HEMA SCREEN SPECIFIC IFOBT
K060463
Immunostics Inc.,
Hematology · 104d
Cleared May 04, 2006
INSURE II
K060930
Enterix, Inc.
Hematology · 29d
Cleared Mar 16, 2006
IMMOCARE
K052598
Care Diagnostic, Inc.
Hematology · 176d
Cleared Oct 03, 2005
CARE FECAL OCCULT BLOOD TEST, MODEL KT313
K051806
Epitope Diagnostics, Inc.
Hematology · 90d

About Product Code KHE - Regulatory Context