KHE · Class II · 21 CFR 864.6550

FDA Product Code KHE: Reagent, Occult Blood

Leading manufacturers include Helena Laboratories, Smithkline Diagnostics, Inc. and Alfa Scientific Designs, 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 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 Jun 21, 2007
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660
Alfa Scientific Designs, Inc.
Hematology · 104d
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 Aug 12, 2004
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202
W.H.P.M., Inc.
Hematology · 97d
Cleared Aug 12, 2004
POLYMEDCO OC LIGHT FOBT TEST
K041297
Polymedco, Inc.
Hematology · 90d
Cleared Nov 24, 2003
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Jun 17, 2002
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423
Alfa Scientific Designs, Inc.
Hematology · 45d
Cleared Nov 27, 2000
COLOSCREEN-ES
K003359
Helena Laboratories
Hematology · 31d
Cleared Dec 06, 1999
COLON ALERT TEST
K992759
Immunostics Inc.,
Hematology · 111d
Cleared May 11, 1999
DBEST OCCULT BLOOD TEST KIT
K984269
Ameritek, Inc.
Hematology · 201d
Cleared Sep 15, 1998
HEMAPROMPT
K981661
Aerscher Diagnostics
Hematology · 132d
Cleared May 12, 1998
COLOSCREEN-ES
K980671
Helena Laboratories
Hematology · 81d
Cleared Oct 20, 1997
HEMAPROMPT
K972763
Aerscher Diagnostics
Hematology · 88d
Cleared Nov 06, 1996
FLEXSURE OBT
K961062
Smithkline Diagnostics, Inc.
Hematology · 233d

About Product Code KHE - Regulatory Context