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Reagent, Occult Blood

FDA product code KHE · 96 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.6550
Review panel: HE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-12-21 – 2018-02-15

KHE 2018-02-15

Instant-view-PLUS immunochemical Fecal Occult Blood Test

Applicant Alfa Scientific Designs, Inc.

K number K173212

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KHE 2017-10-05

InSure ONE

Applicant Enterix, Inc.

K number K170548

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KHE 2017-06-14

hema-screen SPECIFIC Gold

Applicant Immunostics Inc.,

K number K171484

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KHE 2017-05-14

Wondfo One Step Fecal Occult Blood (FOB) Test

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K number K162333

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KHE 2017-01-17

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

Applicant Immunostics Inc.,

K number K163554

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KHE 2012-12-28

OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT

Applicant SEKISUI Diagnostics, LLC

K number K121397

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KHE 2012-12-19

IND ONE STEP OCCULT BLOOD (FOB) TEST

Applicant Ind Diagnostics, Inc.

K number K113506

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KHE 2011-09-14

FOB ONE STEP RAPID TEST

Applicant Orient Gene Biotech

K number K110309

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KHE 2011-01-28

HEMA SCREEN ER

Applicant Immunostics Inc.,

K number K102664

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KHE 2010-07-19

IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10

Applicant Ind Diagnostic, Inc.

K number K100031

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KHE 2010-07-01

BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

Applicant Princeton BioMeditech Corp.

K number K100817

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KHE 2008-06-25

HEMOCCULT ICT

Applicant Beckman Coulter, Inc.

K number K080812

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KHE 2008-03-06

DBEST ONE STEP OCCULT BLOOD TEST KITS

Applicant Ameritek USA, Inc.

K number K071242

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KHE 2008-01-14

FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T

Applicant Tianjin New Bay Bioresearch Co., Ltd.

K number K073431

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KHE 2007-06-21

INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST

Applicant Alfa Scientific Designs, Inc.

K number K070660

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KHE 2007-05-11

FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST

Applicant New Bay Bioresearch Co. , Ltd.

K number K063693

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KHE 2007-03-05

INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE

Applicant Innovacon, Inc.

K number K063673

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KHE 2006-09-18

OCCULTECH FECAL OCCULT BLOOD RAPID TEST

Applicant Yd Diagnostics Corp.

K number K060953

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KHE 2006-07-14

FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25

Applicant Teco Diagnostics

K number K061065

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KHE 2006-06-06

HEMA SCREEN SPECIFIC IFOBT

Applicant Immunostics Inc.,

K number K060463

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KHE 2006-05-04

INSURE II

Applicant Enterix, Inc.

K number K060930

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KHE 2006-03-16

IMMOCARE

Applicant Care Diagnostic, Inc.

K number K052598

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KHE 2005-10-03

CARE FECAL OCCULT BLOOD TEST, MODEL KT313

Applicant Epitope Diagnostics, Inc.

K number K051806

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KHE 2004-08-12

POLYMEDCO OC LIGHT FOBT TEST

Applicant Polymedco, Inc.

K number K041297

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KHE 2004-08-12

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST

Applicant W.H.P.M., Inc.

K number K041202

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KHE 2003-11-24

ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER

Applicant Roche Diagnostics Corp.

K number K033548

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KHE 2003-09-24

HEMAPROMPT GASTRIC

Applicant Aerscher Diagnostics

K number K031356

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KHE 2003-04-02

COLONCARE

Applicant Care Products, Inc.

K number K030216

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KHE 2002-09-24

LIFEGUARD

Applicant Medtek, LLC

K number K022755

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KHE 2002-06-17

INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST

Applicant Alfa Scientific Designs, Inc.

K number K021423

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KHE 2001-02-23

EASE-A-CULT

Applicant Diagnostica, Inc.

K number K002756

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KHE 2001-01-22

INSTACCULT

Applicant Medtek Diagnostics, LLC

K number K002930

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KHE 2001-01-12

!NSURE FECAL OCCULT BLOOD TEST

Applicant Enterix, Inc.

K number K002457

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KHE 2000-11-27

COLOSCREEN-ES

Applicant Helena Laboratories

K number K003359

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KHE 1999-12-06

COLON ALERT TEST

Applicant Immunostics Inc.,

K number K992759

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KHE 1999-05-11

DBEST OCCULT BLOOD TEST KIT

Applicant Ameritek, Inc.

K number K984269

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KHE 1998-09-15

HEMAPROMPT

Applicant Aerscher Diagnostics

K number K981661

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KHE 1998-05-12

COLOSCREEN-ES

Applicant Helena Laboratories

K number K980671

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KHE 1997-10-20

HEMAPROMPT

Applicant Aerscher Diagnostics

K number K972763

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KHE 1996-11-06

FLEXSURE OBT

Applicant Smithkline Diagnostics, Inc.

K number K961062

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KHE 1995-04-05

HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES

Applicant Dipro Diagnostic Products GmbH

K number K936056

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KHE 1992-10-05

PROPPER SUPER SERACULT(R)

Applicant Propper Mfg. Co., Inc.

K number K921798

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KHE 1992-01-31

HEMOPLUS

Applicant Sarstedt, Inc.

K number K913622

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KHE 1991-10-04

HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION

Applicant Labeltape Meditect, Inc.

K number K912979

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KHE 1991-07-03

COLOSCREEN

Applicant Helena Laboratories

K number K911075

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KHE 1991-07-03

COLOCARE

Applicant Helena Laboratories

K number K905798

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KHE 1991-05-06

FHT (FECAL HEME TEST)

Applicant Aerscher, Inc.

K number K905782

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KHE 1990-11-05

MONOHAEM (FECAL OCCULT BLOOD TEST)

Applicant Silenus Laboratories Proprietary , Ltd.

K number K901064

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KHE 1990-07-27

HEMA-SCREEN

Applicant Immunostics Co., Inc.

K number K902360

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KHE 1990-01-25

RESUBMITTED FECATWIN SENSITIVE - FECA-EIA

Applicant Labsystems, Inc.

K number K896474

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KHE 1989-04-18

HEMAWIPE SYSTEM, THE CIVILIZED TEST

Applicant Labeltape Meditect, Inc.

K number K884206

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KHE 1988-10-31

IMMUNOCCULT-LXI

Applicant Intl. Immunoassay Laboratories, Inc.

K number K883432

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KHE 1988-09-30

HELENA COLOCARE

Applicant Helena Laboratories

K number K882799

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KHE 1988-09-30

COLORECTAL CANCER RISK DETECTOR (TM)

Applicant Pearce Clinical Laboratories, Inc.

K number K874180

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KHE 1988-07-08

HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD

Applicant Enzo Biochem, Inc.

K number K881907

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KHE 1988-07-08

IMMUNOCCULT EIA TEST KIT

Applicant Intl. Immunoassay Laboratories, Inc.

K number K871143

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KHE 1988-05-23

HEMOCCULT SENSITIVE TEST

Applicant Smithkline Diagnostics, Inc.

K number K880499

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KHE 1988-05-13

REVISED IMMUDIA HEM-SP

Applicant Schiff & Co.

K number K874482

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KHE 1988-02-11

WAKO(TM) PRETEST 6A

Applicant Wako Chemicals USA, Inc.

K number K873409

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KHE 1986-12-09

HEMOCCULT WIPE TEST

Applicant Smithkline Diagnostics, Inc.

K number K862849

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KHE 1986-11-06

NATURAL DETECTOR SYSTEM

Applicant U.S. Health Resources Corp.

K number K861731

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KHE 1986-05-06

BIOTEL (TM)/ KIDNEY

Applicant American Diagnostic Corp.

K number K855237

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KHE 1986-04-09

EZ DETECH-URINE BLOOD TEST STICKS

Applicant Self Care Systems, Inc.

K number K854358

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KHE 1986-04-07

MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL

Applicant Self Care Systems, Inc.

K number K860028

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KHE 1986-03-03

DETECTACULT

Applicant Immunostics Co., Inc.

K number K854619

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KHE 1985-11-18

ACCESS DIGIWIPE SYSTEM

Applicant Medtech Products, Inc.

K number K853141

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KHE 1985-06-17

EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL

Applicant Nms Pharmaceuticals, Inc.

K number K850431

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KHE 1985-01-04

ACCESS HEMAWIPE

Applicant Medtech Products, Inc.

K number K843601

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KHE 1984-12-12

UROPAPER EIKEN 8

Applicant Syn-Kit, Inc.

K number K843532

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KHE 1984-12-05

COLOSCREEN SELF-TEST

Applicant Helena Laboratories

K number K843352

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KHE 1984-09-05

OCCULT BLOOD TEST

Applicant Breit Laboratories, Inc.

K number K842137

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KHE 1984-09-05

COLOTRAK OCCULT BLOOD TEST

Applicant Breit Laboratories, Inc.

K number K840527

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KHE 1984-08-16

ACCU-CULT FECAL OCCULT BLOOD TEST

Applicant Applied Medical Devices, Inc.

K number K840904

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KHE 1984-08-10

HELENA COLOSCREEN SELF-TEST

Applicant Helena Laboratories

K number K840903

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KHE 1984-08-02

EARLY DETECTOR

Applicant Warner-Lambert Co.

K number K833369

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KHE 1984-02-27

HEMOCCULT-C

Applicant Menley & James Laboratories

K number K832311

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KHE 1984-01-27

PROPPER SERACULT

Applicant Propper Mfg. Co., Inc.

K number K834297

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KHE 1984-01-13

HELENA BIO STRIP OB

Applicant Helena Laboratories

K number K834456

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KHE 1983-11-21

COLOSCREEN V.P.I.

Applicant Helena Laboratories

K number K832864

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KHE 1983-07-07

OCCULT-ALERT

Applicant Beta Med Pharmaceuticals, Inc.

K number K830919

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KHE 1983-03-07

FECAL OCCULT SLIDE TEST KIT

Applicant Cambridge Chemical Products, Inc.

K number K830223

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KHE 1982-10-18

HEMOTECT

Applicant Bio-Chem Laboratories

K number K822731

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KHE 1982-10-08

GASTROCCULT TM

Applicant Smithkline Diagnostics, Inc.

K number K821884

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KHE 1982-07-02

FLEET DETECTATEST

Applicant C.B. Fleet Co., Inc.

K number K812728

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KHE 1982-03-04

FE-CULT PLUS

Applicant Gamma Biologicals, Inc.

K number K820072

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KHE 1982-01-28

SERACULT OCCULT BLOOF TEST

Applicant Propper Mfg. Co., Inc.

K number K813204

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KHE 1981-12-10

UROPAPER EIKEG

Applicant Syn-Kit, Inc.

K number K811815

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KHE 1981-11-02

FE-CULT PLUS

Applicant Gamma Biologicals, Inc.

K number K811752

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KHE 1981-10-23

HELENA COLOSCREEN METHOD

Applicant Helena Laboratories

K number K812428

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KHE 1981-05-08

HOME HEALTH CHEKUP KIT

Applicant Healthkit

K number K810488

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KHE 1980-05-02

HELENA COLOCHECK

Applicant Helena Laboratories

K number K800433

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KHE 1980-01-24

HELENA COLOSCREEN

Applicant Helena Laboratories

K number K792655

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KHE 1978-06-30

FECATEST

Applicant Otto C. Watzka

K number K780564

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KHE 1978-05-03

HEMO FEC

Applicant Boehringer Mannheim Corp.

K number K780214

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KHE 1977-02-08

CAMCO R PAK-GUAIAC

Applicant Cambridge Chemical Products, Inc.

K number K770153

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KHE 1976-12-21

QUICK CULT SLIDE TEST FECAL OCCULT BLOOD

Applicant Laboratory Diagnostics Co., Inc.

K number K761232

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