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 |