FDA 510(k) Applications for Medical Device Product Code "KHE"
(Reagent, Occult Blood)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K972763 | AERSCHER DIAGNOSTICS | HEMAPROMPT | 10/20/1997 |
| K981661 | AERSCHER DIAGNOSTICS | HEMAPROMPT | 09/15/1998 |
| K031356 | AERSCHER DIAGNOSTICS | HEMAPROMPT GASTRIC | 09/24/2003 |
| K070660 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | 06/21/2007 |
| K021423 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | 06/17/2002 |
| K173212 | Alfa Scientific Designs, Inc. | Instant-view-PLUS immunochemical Fecal Occult Blood Test | 02/15/2018 |
| K071242 | AMERITEK USA, INC. | DBEST ONE STEP OCCULT BLOOD TEST KITS | 03/06/2008 |
| K984269 | AMERITEK, INC. | DBEST OCCULT BLOOD TEST KIT | 05/11/1999 |
| K080812 | BECKMAN COULTER, INC. | HEMOCCULT ICT | 06/25/2008 |
| K052598 | CARE DIAGNOSTIC, INC. | IMMOCARE | 03/16/2006 |
| K030216 | CARE PRODUCTS, INC. | COLONCARE | 04/02/2003 |
| K002756 | DIAGNOSTICA, INC. | EASE-A-CULT | 02/23/2001 |
| K143325 | EIKEN CHEMICAL CO. LTD | OC-Light S FIT | 08/20/2015 |
| K002457 | ENTERIX INC. | !NSURE FECAL OCCULT BLOOD TEST | 01/12/2001 |
| K060930 | ENTERIX INC. | INSURE II | 05/04/2006 |
| K170548 | Enterix Inc. | InSure ONE | 10/05/2017 |
| K051806 | EPITOPE DIAGNOSTICS, INC. | CARE FECAL OCCULT BLOOD TEST, MODEL KT313 | 10/03/2005 |
| K162333 | GUANGZHOU WONDFO BIOTECH CO., LTD. | Wondfo One Step Fecal Occult Blood (FOB) Test | 05/14/2017 |
| K003359 | HELENA LABORATORIES | COLOSCREEN-ES | 11/27/2000 |
| K980671 | HELENA LABORATORIES | COLOSCREEN-ES | 05/12/1998 |
| K992759 | IMMUNOSTICS, INC. | COLON ALERT TEST | 12/06/1999 |
| K102664 | IMMUNOSTICS, INC. | HEMA SCREEN ER | 01/28/2011 |
| K060463 | IMMUNOSTICS, INC. | HEMA SCREEN SPECIFIC IFOBT | 06/06/2006 |
| K163554 | Immunostics, Inc. | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | 01/17/2017 |
| K171484 | Immunostics, Inc. | hema-screen SPECIFIC Gold | 06/14/2017 |
| K100031 | IND DIAGNOSTIC INC. | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | 07/19/2010 |
| K113506 | IND DIAGNOSTICS INC. | IND ONE STEP OCCULT BLOOD (FOB) TEST | 12/19/2012 |
| K063673 | INNOVACON, INC. | INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE | 03/05/2007 |
| K002930 | MEDTEK DIAGNOSTICS, LLC. | INSTACCULT | 01/22/2001 |
| K022755 | MEDTEK LLC. | LIFEGUARD | 09/24/2002 |
| K063693 | NEW BAY BIORESEARCH CO. LTD. | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST | 05/11/2007 |
| K110309 | ORIENT GENE BIOTECH | FOB ONE STEP RAPID TEST | 09/14/2011 |
| K041297 | POLYMEDCO, INC. | POLYMEDCO OC LIGHT FOBT TEST | 08/12/2004 |
| K100817 | PRINCETON BIOMEDITECH CORP. | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | 07/01/2010 |
| K033548 | ROCHE DIAGNOSTICS CORP. | ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER | 11/24/2003 |
| K121397 | SEKISUI DIAGNOSTICS, LLC | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT | 12/28/2012 |
| K961062 | SMITHKLINE DIAGNOSTICS, INC. | FLEXSURE OBT | 11/06/1996 |
| K061065 | TECO DIAGNOSTICS | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 | 07/14/2006 |
| K073431 | Tianjin New Bay Bioresearch Co., Ltd. | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T | 01/14/2008 |
| K041202 | W.H.P.M., INC. | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST | 08/12/2004 |
| K060953 | YD DIAGNOSTICS CORP. | OCCULTECH FECAL OCCULT BLOOD RAPID TEST | 09/18/2006 |
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