Product Code: KHE


Products Classified as KHE

2375Reagent, Occult BloodOccult Blood Test.

Total Product Life Cycle (TPLC) Devices

2375Reagent, Occult BloodOccult Blood Test.

Pre-market Notifications for KHE

K173212Instant-view-PLUS Immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.
K171484Hema-screen SPECIFIC GoldImmunostics, Inc.
K170548InSure ONEEnterix Inc.
K163554Hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics, Inc.
K162333Wondfo One Step Fecal Occult Blood (FOB) TestGUANGZHOU WONDFO BIOTECH CO., LTD.
K143325OC-Light S FITEIKEN CHEMICAL CO. LTD
K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KITSEKISUI DIAGNOSTICS, LLC
K113506IND ONE STEP OCCULT BLOOD (FOB) TESTIND DIAGNOSTICS INC.
K110309FOB ONE STEP RAPID TESTORIENT GENE BIOTECH
K102664HEMA SCREEN ERIMMUNOSTICS, INC.
K100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TESTPRINCETON BIOMEDITECH CORP.
K100031IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10IND DIAGNOSTIC INC.
K080812HEMOCCULT ICTBECKMAN COULTER, INC.
K073431FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME TTianjin New Bay Bioresearch Co., Ltd.
K071242DBEST ONE STEP OCCULT BLOOD TEST KITSAMERITEK USA, INC.

Global Unique Device Identification Database

10304040054182REAGENT, OCCULT BLOOD
20304040016767REAGENT, OCCULT BLOOD
20304040016750REAGENT, OCCULT BLOOD
10304040002596REAGENT, OCCULT BLOOD
10304040002589REAGENT, OCCULT BLOOD
10304040002565REAGENT, OCCULT BLOOD
10304040002558REAGENT, OCCULT BLOOD
10304040002541REAGENT, OCCULT BLOOD
10304040002534REAGENT, OCCULT BLOOD
10304040002527REAGENT, OCCULT BLOOD
00613647100035REAGENT, OCCULT BLOOD
00613647001066REAGENT, OCCULT BLOOD
00613647001059REAGENT, OCCULT BLOOD
00613647001042REAGENT, OCCULT BLOOD
00613647000700REAGENT, OCCULT BLOOD

Maude Adverse Events

HEMAPROMPT FGAERSCHER DIAGNOSTICS2020-03-11
66040 GASTROCCULT TEST FOR GASTRIC OCCULT BLOOD AND PH 40 TEST SLIDESBECKMAN COULTER, INC.2019-08-16
HEMOCCULTBECKMAN COULTER, INC.2018-10-30
OC-AUTO FITPOLYMEDCO2017-12-28
HEMAPROMPT FGAERSCHER DIAGNOSTICS2016-07-15
AMERICAN PROFICIENCY INSTITUTEAMERICAN PROFICIENCY INSTITUTE2016-03-22
HEMOCCULT II SENSABECKMAN COULTER, INC.2016-02-19
URISYS 1100ROCHE DIAGNOSTICS2015-11-10
URISYS 1100ROCHE DIAGNOSTICS2015-11-10
URISYS 1100ROCHE DIAGNOSTICS2015-11-03
URISYS 1100ROCHE DIAGNOSTICS2015-10-24
URISYS 1100ROCHE DIAGNOSTICS2015-07-30
URISYS 1100ROCHE DIAGNOSTICS2015-06-23
URISYS 1100ROCHE DIAGNOSTICS2015-03-09
URISYS 1100ROCHE DIAGNOSTICS2015-02-25
URISYS 1100ROCHE DIAGNOSTICS2015-02-25
URISYS 1100ROCHE DIAGNOSTICS2015-02-25
URISYS 1100ROCHE DIAGNOSTICS2014-11-13
URISYS 1100ROCHE DIAGNOSTICS2014-08-26
URISYS 1100ROCHE DIAGNOSTICS2014-08-26
URISYS 1100ROCHE DIAGNOSTICS2014-06-24
URISYS 1100ROCHE DIAGNOSTICS2014-03-27
URISYS 1100ROCHE DIAGNOSTICS2014-01-13
URISYS 1100ROCHE DIAGNOSTICS2013-11-14
URISYS 1100ROCHE DIAGNOSTICS2013-11-04
URISYS 1100ROCHE DIAGNOSTICS2013-09-05
HEMOCCULT? DEVELOPERBECKMAN COULTER2013-09-02
HEMOCCULT? ICT TEST DEVICEBECKMAN COULTER2013-06-03
HEMOCCULT? ICT TEST DEVICEBECKMAN COULTER2013-06-03
HEMOCCULT? ICT TEST DEVICEBECKMAN COULTER2013-06-03
HEMOCCULT? ICT TEST DEVICEBECKMAN COULTER2013-06-03
HEMOCCULT? ICT TEST DEVICEBECKMAN COULTER2013-06-03
HEMOCCULT? ICT TEST DEVICEBECKMAN COULTER2013-06-03
HEMOCCULT? ICT TEST DEVICEBECKMAN COULTER2013-06-03
HEMOCCULT? ICT TEST DEVICEBECKMAN COULTER2013-06-03
URISYS 1100ROCHE DIAGNOSTICS2013-05-06
URISYS 1100ROCHE DIAGNOSTICS2013-03-29
URISYS 1100ROCHE DIAGNOSTICS2013-02-20
HEMOCCULT SENSA TEST FOR FECAL OCCULT BLOODBECKMAN COULTER, INC.2013-01-10
URISYS 1100ROCHE DIAGNOSTICS2012-12-21
URISYS 1100ROCHE DIAGNOSTICS2012-11-20
URISYS 1100ROCHE DIAGNOSTICS2012-04-04
GASTROCCULTBECKMAN COULTER2011-10-10
URISYS 1100ROCHE DIAGNOSTICS2011-03-14
HEMOCCULT ICTBECKMAN COULTER INC2011-02-25
URISYS 1100ROCHE DIAGNOSTICS2011-02-03
URISYS 1100ROCHE DIAGNOSTICS2010-12-13
URISYS 1100ROCHE DIAGNOSTICS2010-06-01
URISYS 1100ROCHE DIAGNOSTICS2010-04-26
URISYS 1100ROCHE DIAGNOSTICS2010-01-21

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