| Instant-view-PLUS immunochemical Fecal Occult Blood Test (K173212) | Alfa Scientific Designs, Inc. | 2018-02-15 |
| InSure ONE (K170548) | Enterix, Inc. | 2017-10-05 |
| hema-screen SPECIFIC Gold (K171484) | Immunostics Inc., | 2017-06-14 |
| Wondfo One Step Fecal Occult Blood (FOB) Test (K162333) | Guangzhou Wondfo Biotech Co., Ltd. | 2017-05-14 |
| hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (K163554) | Immunostics Inc., | 2017-01-17 |
| OC-Light S FIT (K143325) | Eiken Chemical Co., Ltd. | 2015-08-20 |
| OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT (K121397) | SEKISUI Diagnostics, LLC | 2012-12-28 |
| IND ONE STEP OCCULT BLOOD (FOB) TEST (K113506) | Ind Diagnostics, Inc. | 2012-12-19 |
| FOB ONE STEP RAPID TEST (K110309) | Orient Gene Biotech | 2011-09-14 |
| HEMA SCREEN ER (K102664) | Immunostics Inc., | 2011-01-28 |
| IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 (K100031) | Ind Diagnostic, Inc. | 2010-07-19 |
| BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST (K100817) | Princeton BioMeditech Corp. | 2010-07-01 |
| HEMOCCULT ICT (K080812) | Beckman Coulter, Inc. | 2008-06-25 |
| DBEST ONE STEP OCCULT BLOOD TEST KITS (K071242) | Ameritek USA, Inc. | 2008-03-06 |
| FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T (K073431) | Tianjin New Bay Bioresearch Co., Ltd. | 2008-01-14 |
| INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST (K070660) | Alfa Scientific Designs, Inc. | 2007-06-21 |
| FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST (K063693) | New Bay Bioresearch Co. , Ltd. | 2007-05-11 |
| INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE (K063673) | Innovacon, Inc. | 2007-03-05 |
| OCCULTECH FECAL OCCULT BLOOD RAPID TEST (K060953) | Yd Diagnostics Corp. | 2006-09-18 |
| FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 (K061065) | Teco Diagnostics | 2006-07-14 |
| HEMA SCREEN SPECIFIC IFOBT (K060463) | Immunostics Inc., | 2006-06-06 |
| INSURE II (K060930) | Enterix, Inc. | 2006-05-04 |
| IMMOCARE (K052598) | Care Diagnostic, Inc. | 2006-03-16 |
| CARE FECAL OCCULT BLOOD TEST, MODEL KT313 (K051806) | Epitope Diagnostics, Inc. | 2005-10-03 |
| POLYMEDCO OC LIGHT FOBT TEST (K041297) | Polymedco, Inc. | 2004-08-12 |
| HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST (K041202) | W.H.P.M., Inc. | 2004-08-12 |
| ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER (K033548) | Roche Diagnostics Corp. | 2003-11-24 |
| HEMAPROMPT GASTRIC (K031356) | Aerscher Diagnostics | 2003-09-24 |
| COLONCARE (K030216) | Care Products, Inc. | 2003-04-02 |
| LIFEGUARD (K022755) | Medtek, LLC | 2002-09-24 |
| INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST (K021423) | Alfa Scientific Designs, Inc. | 2002-06-17 |
| EASE-A-CULT (K002756) | Diagnostica, Inc. | 2001-02-23 |
| INSTACCULT (K002930) | Medtek Diagnostics, LLC | 2001-01-22 |
| !NSURE FECAL OCCULT BLOOD TEST (K002457) | Enterix, Inc. | 2001-01-12 |
| COLOSCREEN-ES (K003359) | Helena Laboratories | 2000-11-27 |
| COLON ALERT TEST (K992759) | Immunostics Inc., | 1999-12-06 |
| DBEST OCCULT BLOOD TEST KIT (K984269) | Ameritek, Inc. | 1999-05-11 |
| HEMAPROMPT (K981661) | Aerscher Diagnostics | 1998-09-15 |
| COLOSCREEN-ES (K980671) | Helena Laboratories | 1998-05-12 |
| HEMAPROMPT (K972763) | Aerscher Diagnostics | 1997-10-20 |
| FLEXSURE OBT (K961062) | Smithkline Diagnostics, Inc. | 1996-11-06 |
| HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES (K936056) | Dipro Diagnostic Products GmbH | 1995-04-05 |
| PROPPER SUPER SERACULT(R) (K921798) | Propper Mfg. Co., Inc. | 1992-10-05 |
| HEMOPLUS (K913622) | Sarstedt, Inc. | 1992-01-31 |
| HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION (K912979) | Labeltape Meditect, Inc. | 1991-10-04 |
| COLOCARE (K905798) | Helena Laboratories | 1991-07-03 |
| COLOSCREEN (K911075) | Helena Laboratories | 1991-07-03 |
| FHT (FECAL HEME TEST) (K905782) | Aerscher, Inc. | 1991-05-06 |
| MONOHAEM (FECAL OCCULT BLOOD TEST) (K901064) | Silenus Laboratories Proprietary , Ltd. | 1990-11-05 |
| HEMA-SCREEN (K902360) | Immunostics Co., Inc. | 1990-07-27 |
| RESUBMITTED FECATWIN SENSITIVE - FECA-EIA (K896474) | Labsystems, Inc. | 1990-01-25 |
| HEMAWIPE SYSTEM, THE CIVILIZED TEST (K884206) | Labeltape Meditect, Inc. | 1989-04-18 |
| IMMUNOCCULT-LXI (K883432) | Intl. Immunoassay Laboratories, Inc. | 1988-10-31 |
| COLORECTAL CANCER RISK DETECTOR (TM) (K874180) | Pearce Clinical Laboratories, Inc. | 1988-09-30 |
| HELENA COLOCARE (K882799) | Helena Laboratories | 1988-09-30 |
| HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD (K881907) | Enzo Biochem, Inc. | 1988-07-08 |
| IMMUNOCCULT EIA TEST KIT (K871143) | Intl. Immunoassay Laboratories, Inc. | 1988-07-08 |
| HEMOCCULT SENSITIVE TEST (K880499) | Smithkline Diagnostics, Inc. | 1988-05-23 |
| REVISED IMMUDIA HEM-SP (K874482) | Schiff & Co. | 1988-05-13 |
| WAKO(TM) PRETEST 6A (K873409) | Wako Chemicals USA, Inc. | 1988-02-11 |
| HEMOCCULT WIPE TEST (K862849) | Smithkline Diagnostics, Inc. | 1986-12-09 |
| NATURAL DETECTOR SYSTEM (K861731) | U.S. Health Resources Corp. | 1986-11-06 |
| BIOTEL (TM)/ KIDNEY (K855237) | American Diagnostic Corp. | 1986-05-06 |
| EZ DETECH-URINE BLOOD TEST STICKS (K854358) | Self Care Systems, Inc. | 1986-04-09 |
| MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL (K860028) | Self Care Systems, Inc. | 1986-04-07 |
| DETECTACULT (K854619) | Immunostics Co., Inc. | 1986-03-03 |
| ACCESS DIGIWIPE SYSTEM (K853141) | Medtech Products, Inc. | 1985-11-18 |
| EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL (K850431) | Nms Pharmaceuticals, Inc. | 1985-06-17 |
| ACCESS HEMAWIPE (K843601) | Medtech Products, Inc. | 1985-01-04 |
| UROPAPER EIKEN 8 (K843532) | Syn-Kit, Inc. | 1984-12-12 |
| COLOSCREEN SELF-TEST (K843352) | Helena Laboratories | 1984-12-05 |
| OCCULT BLOOD TEST (K842137) | Breit Laboratories, Inc. | 1984-09-05 |
| COLOTRAK OCCULT BLOOD TEST (K840527) | Breit Laboratories, Inc. | 1984-09-05 |
| ACCU-CULT FECAL OCCULT BLOOD TEST (K840904) | Applied Medical Devices, Inc. | 1984-08-16 |
| HELENA COLOSCREEN SELF-TEST (K840903) | Helena Laboratories | 1984-08-10 |
| EARLY DETECTOR (K833369) | Warner-Lambert Co. | 1984-08-02 |
| HEMOCCULT-C (K832311) | Menley & James Laboratories | 1984-02-27 |
| PROPPER SERACULT (K834297) | Propper Mfg. Co., Inc. | 1984-01-27 |
| HELENA BIO STRIP OB (K834456) | Helena Laboratories | 1984-01-13 |
| COLOSCREEN V.P.I. (K832864) | Helena Laboratories | 1983-11-21 |
| OCCULT-ALERT (K830919) | Beta Med Pharmaceuticals, Inc. | 1983-07-07 |
| FECAL OCCULT SLIDE TEST KIT (K830223) | Cambridge Chemical Products, Inc. | 1983-03-07 |
| HEMOTECT (K822731) | Bio-Chem Laboratories | 1982-10-18 |
| GASTROCCULT TM (K821884) | Smithkline Diagnostics, Inc. | 1982-10-08 |
| FLEET DETECTATEST (K812728) | C.B. Fleet Co., Inc. | 1982-07-02 |
| FE-CULT PLUS (K820072) | Gamma Biologicals, Inc. | 1982-03-04 |
| SERACULT OCCULT BLOOF TEST (K813204) | Propper Mfg. Co., Inc. | 1982-01-28 |
| UROPAPER EIKEG (K811815) | Syn-Kit, Inc. | 1981-12-10 |
| FE-CULT PLUS (K811752) | Gamma Biologicals, Inc. | 1981-11-02 |
| HELENA COLOSCREEN METHOD (K812428) | Helena Laboratories | 1981-10-23 |
| HOME HEALTH CHEKUP KIT (K810488) | Healthkit | 1981-05-08 |
| HELENA COLOCHECK (K800433) | Helena Laboratories | 1980-05-02 |
| HELENA COLOSCREEN (K792655) | Helena Laboratories | 1980-01-24 |
| FECATEST (K780564) | Otto C. Watzka | 1978-06-30 |
| HEMO FEC (K780214) | Boehringer Mannheim Corp. | 1978-05-03 |
| CAMCO R PAK-GUAIAC (K770153) | Cambridge Chemical Products, Inc. | 1977-02-08 |
| QUICK CULT SLIDE TEST FECAL OCCULT BLOOD (K761232) | Laboratory Diagnostics Co., Inc. | 1976-12-21 |