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 May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333
Guangzhou Wondfo Biotech Co., Ltd.
Hematology · 265d
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 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 May 12, 1998
COLOSCREEN-ES
K980671
Helena Laboratories
Hematology · 81d
Cleared Nov 06, 1996
FLEXSURE OBT
K961062
Smithkline Diagnostics, Inc.
Hematology · 233d
Cleared Jul 03, 1991
COLOCARE
K905798
Helena Laboratories
Hematology · 226d
Cleared Jul 03, 1991
COLOSCREEN
K911075
Helena Laboratories
Hematology · 114d
Cleared Sep 30, 1988
HELENA COLOCARE
K882799
Helena Laboratories
Hematology · 86d
Cleared May 23, 1988
HEMOCCULT SENSITIVE TEST
K880499
Smithkline Diagnostics, Inc.
Hematology · 108d
Cleared Feb 11, 1988
WAKO(TM) PRETEST 6A
K873409
Wako Chemicals USA, Inc.
Chemistry · 170d
Cleared Dec 09, 1986
HEMOCCULT WIPE TEST
K862849
Smithkline Diagnostics, Inc.
Hematology · 133d
Cleared May 06, 1986
BIOTEL (TM)/ KIDNEY
K855237
American Diagnostic Corp.
Hematology · 126d
Cleared Dec 05, 1984
COLOSCREEN SELF-TEST
K843352
Helena Laboratories
Hematology · 100d
Cleared Aug 10, 1984
HELENA COLOSCREEN SELF-TEST
K840903
Helena Laboratories
Hematology · 164d
Cleared Aug 02, 1984
EARLY DETECTOR
K833369
Warner-Lambert Co.
Hematology · 310d
Cleared Jan 13, 1984
HELENA BIO STRIP OB
K834456
Helena Laboratories
Chemistry · 25d
Cleared Nov 21, 1983
COLOSCREEN V.P.I.
K832864
Helena Laboratories
Immunology · 90d
Cleared Oct 08, 1982
GASTROCCULT TM
K821884
Smithkline Diagnostics, Inc.
Hematology · 105d

About Product Code KHE - Regulatory Context