FDA Product Code
FDA Product Code KHE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.6550
510(k) Clearances — 97 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | 2018-02-15 | Traditional | PDF ↗ |
| K170548 | InSure ONE | Enterix, Inc. | 2017-10-05 | Traditional | PDF ↗ |
| K171484 | hema-screen SPECIFIC Gold | Immunostics Inc., | 2017-06-14 | Special | PDF ↗ |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | Guangzhou Wondfo Biotech Co., Ltd. | 2017-05-14 | Traditional | PDF ↗ |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | Immunostics Inc., | 2017-01-17 | Special | PDF ↗ |
| K143325 | OC-Light S FIT | Eiken Chemical Co., Ltd. | 2015-08-20 | Traditional | PDF ↗ |
| K121397 | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT | SEKISUI Diagnostics, LLC | 2012-12-28 | Traditional | PDF ↗ |
| K113506 | IND ONE STEP OCCULT BLOOD (FOB) TEST | Ind Diagnostics, Inc. | 2012-12-19 | Special | PDF ↗ |
| K110309 | FOB ONE STEP RAPID TEST | Orient Gene Biotech | 2011-09-14 | Traditional | PDF ↗ |
| K102664 | HEMA SCREEN ER | Immunostics Inc., | 2011-01-28 | Special | PDF ↗ |
| K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | Ind Diagnostic, Inc. | 2010-07-19 | Traditional | PDF ↗ |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Princeton BioMeditech Corp. | 2010-07-01 | Traditional | PDF ↗ |
| K080812 | HEMOCCULT ICT | Beckman Coulter, Inc. | 2008-06-25 | Traditional | PDF ↗ |
| K071242 | DBEST ONE STEP OCCULT BLOOD TEST KITS | Ameritek USA, Inc. | 2008-03-06 | Traditional | PDF ↗ |
| K073431 | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T | Tianjin New Bay Bioresearch Co., Ltd. | 2008-01-14 | Special | PDF ↗ |
| K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | Alfa Scientific Designs, Inc. | 2007-06-21 | Traditional | PDF ↗ |
| K063693 | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST | New Bay Bioresearch Co. , Ltd. | 2007-05-11 | Traditional | PDF ↗ |
| K063673 | INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE | Innovacon, Inc. | 2007-03-05 | Traditional | PDF ↗ |
| K060953 | OCCULTECH FECAL OCCULT BLOOD RAPID TEST | Yd Diagnostics Corp. | 2006-09-18 | Traditional | PDF ↗ |
| K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 | Teco Diagnostics | 2006-07-14 | Traditional | PDF ↗ |
| K060463 | HEMA SCREEN SPECIFIC IFOBT | Immunostics Inc., | 2006-06-06 | Traditional | PDF ↗ |
| K060930 | INSURE II | Enterix, Inc. | 2006-05-04 | Special | PDF ↗ |
| K052598 | IMMOCARE | Care Diagnostic, Inc. | 2006-03-16 | Traditional | PDF ↗ |
| K051806 | CARE FECAL OCCULT BLOOD TEST, MODEL KT313 | Epitope Diagnostics, Inc. | 2005-10-03 | Traditional | PDF ↗ |
| K041202 | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST | W.H.P.M., Inc. | 2004-08-12 | Traditional | PDF ↗ |
| K041297 | POLYMEDCO OC LIGHT FOBT TEST | Polymedco, Inc. | 2004-08-12 | Traditional | PDF ↗ |
| K033548 | ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER | Roche Diagnostics Corp. | 2003-11-24 | Special | PDF ↗ |
| K031356 | HEMAPROMPT GASTRIC | Aerscher Diagnostics | 2003-09-24 | Traditional | PDF ↗ |
| K030216 | COLONCARE | Care Products, Inc. | 2003-04-02 | Traditional | PDF ↗ |
| K022755 | LIFEGUARD | Medtek, LLC | 2002-09-24 | Traditional | PDF ↗ |
| K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | Alfa Scientific Designs, Inc. | 2002-06-17 | Abbreviated | PDF ↗ |
| K002756 | EASE-A-CULT | Diagnostica, Inc. | 2001-02-23 | Traditional | PDF ↗ |
| K002930 | INSTACCULT | Medtek Diagnostics, LLC | 2001-01-22 | Traditional | PDF ↗ |
| K002457 | !NSURE FECAL OCCULT BLOOD TEST | Enterix, Inc. | 2001-01-12 | Traditional | PDF ↗ |
| K003359 | COLOSCREEN-ES | Helena Laboratories | 2000-11-27 | Traditional | PDF ↗ |
| K992759 | COLON ALERT TEST | Immunostics Inc., | 1999-12-06 | Traditional | PDF ↗ |
| K984269 | DBEST OCCULT BLOOD TEST KIT | Ameritek, Inc. | 1999-05-11 | Traditional | PDF ↗ |
| K981661 | HEMAPROMPT | Aerscher Diagnostics | 1998-09-15 | Traditional | PDF ↗ |
| K980671 | COLOSCREEN-ES | Helena Laboratories | 1998-05-12 | Traditional | PDF ↗ |
| K972763 | HEMAPROMPT | Aerscher Diagnostics | 1997-10-20 | Traditional | PDF ↗ |
| K961062 | FLEXSURE OBT | Smithkline Diagnostics, Inc. | 1996-11-06 | Traditional | PDF ↗ |
| K936056 | HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES | Dipro Diagnostic Products GmbH | 1995-04-05 | Traditional | PDF ↗ |
| K921798 | PROPPER SUPER SERACULT(R) | Propper Mfg. Co., Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K913622 | HEMOPLUS | Sarstedt, Inc. | 1992-01-31 | Traditional | PDF ↗ |
| K912979 | HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION | Labeltape Meditect, Inc. | 1991-10-04 | Traditional | PDF ↗ |
| K911075 | COLOSCREEN | Helena Laboratories | 1991-07-03 | Traditional | PDF ↗ |
| K905798 | COLOCARE | Helena Laboratories | 1991-07-03 | Traditional | PDF ↗ |
| K905782 | FHT (FECAL HEME TEST) | Aerscher, Inc. | 1991-05-06 | Traditional | PDF ↗ |
| K901064 | MONOHAEM (FECAL OCCULT BLOOD TEST) | Silenus Laboratories Proprietary , Ltd. | 1990-11-05 | Traditional | PDF ↗ |
| K902360 | HEMA-SCREEN | Immunostics Co., Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K896474 | RESUBMITTED FECATWIN SENSITIVE - FECA-EIA | Labsystems, Inc. | 1990-01-25 | Traditional | PDF ↗ |
| K884206 | HEMAWIPE SYSTEM, THE CIVILIZED TEST | Labeltape Meditect, Inc. | 1989-04-18 | Traditional | PDF ↗ |
| K883432 | IMMUNOCCULT-LXI | Intl. Immunoassay Laboratories, Inc. | 1988-10-31 | Traditional | PDF ↗ |
| K874180 | COLORECTAL CANCER RISK DETECTOR (TM) | Pearce Clinical Laboratories, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K882799 | HELENA COLOCARE | Helena Laboratories | 1988-09-30 | Traditional | PDF ↗ |
| K871143 | IMMUNOCCULT EIA TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K881907 | HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD | Enzo Biochem, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K880499 | HEMOCCULT SENSITIVE TEST | Smithkline Diagnostics, Inc. | 1988-05-23 | Traditional | PDF ↗ |
| K874482 | REVISED IMMUDIA HEM-SP | Schiff & Co. | 1988-05-13 | Traditional | PDF ↗ |
| K873409 | WAKO(TM) PRETEST 6A | Wako Chemicals USA, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K862849 | HEMOCCULT WIPE TEST | Smithkline Diagnostics, Inc. | 1986-12-09 | Traditional | PDF ↗ |
| K861731 | NATURAL DETECTOR SYSTEM | U.S. Health Resources Corp. | 1986-11-06 | Traditional | PDF ↗ |
| K855237 | BIOTEL (TM)/ KIDNEY | American Diagnostic Corp. | 1986-05-06 | Traditional | PDF ↗ |
| K854358 | EZ DETECH-URINE BLOOD TEST STICKS | Self Care Systems, Inc. | 1986-04-09 | Traditional | PDF ↗ |
| K860028 | MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL | Self Care Systems, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K854619 | DETECTACULT | Immunostics Co., Inc. | 1986-03-03 | Traditional | PDF ↗ |
| K853141 | ACCESS DIGIWIPE SYSTEM | Medtech Products, Inc. | 1985-11-18 | Traditional | PDF ↗ |
| K850431 | EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL | Nms Pharmaceuticals, Inc. | 1985-06-17 | Traditional | PDF ↗ |
| K843601 | ACCESS HEMAWIPE | Medtech Products, Inc. | 1985-01-04 | Traditional | PDF ↗ |
| K843532 | UROPAPER EIKEN 8 | Syn-Kit, Inc. | 1984-12-12 | Traditional | PDF ↗ |
| K843352 | COLOSCREEN SELF-TEST | Helena Laboratories | 1984-12-05 | Traditional | PDF ↗ |
| K840527 | COLOTRAK OCCULT BLOOD TEST | Breit Laboratories, Inc. | 1984-09-05 | Traditional | PDF ↗ |
| K842137 | OCCULT BLOOD TEST | Breit Laboratories, Inc. | 1984-09-05 | Traditional | PDF ↗ |
| K840904 | ACCU-CULT FECAL OCCULT BLOOD TEST | Applied Medical Devices, Inc. | 1984-08-16 | Traditional | PDF ↗ |
| K840903 | HELENA COLOSCREEN SELF-TEST | Helena Laboratories | 1984-08-10 | Traditional | PDF ↗ |
| K833369 | EARLY DETECTOR | Warner-Lambert Co. | 1984-08-02 | Traditional | PDF ↗ |
| K832311 | HEMOCCULT-C | Menley & James Laboratories | 1984-02-27 | Traditional | PDF ↗ |
| K834297 | PROPPER SERACULT | Propper Mfg. Co., Inc. | 1984-01-27 | Traditional | PDF ↗ |
| K834456 | HELENA BIO STRIP OB | Helena Laboratories | 1984-01-13 | Traditional | PDF ↗ |
| K832864 | COLOSCREEN V.P.I. | Helena Laboratories | 1983-11-21 | Traditional | PDF ↗ |
| K830919 | OCCULT-ALERT | Beta Med Pharmaceuticals, Inc. | 1983-07-07 | Traditional | PDF ↗ |
| K830223 | FECAL OCCULT SLIDE TEST KIT | Cambridge Chemical Products, Inc. | 1983-03-07 | Traditional | PDF ↗ |
| K822731 | HEMOTECT | Bio-Chem Laboratories | 1982-10-18 | Traditional | PDF ↗ |
| K821884 | GASTROCCULT TM | Smithkline Diagnostics, Inc. | 1982-10-08 | Traditional | PDF ↗ |
| K812728 | FLEET DETECTATEST | C.B. Fleet Co., Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K820072 | FE-CULT PLUS | Gamma Biologicals, Inc. | 1982-03-04 | Traditional | PDF ↗ |
| K813204 | SERACULT OCCULT BLOOF TEST | Propper Mfg. Co., Inc. | 1982-01-28 | Traditional | PDF ↗ |
| K811815 | UROPAPER EIKEG | Syn-Kit, Inc. | 1981-12-10 | Traditional | PDF ↗ |
| K811752 | FE-CULT PLUS | Gamma Biologicals, Inc. | 1981-11-02 | Traditional | PDF ↗ |
| K812428 | HELENA COLOSCREEN METHOD | Helena Laboratories | 1981-10-23 | Traditional | PDF ↗ |
| K810488 | HOME HEALTH CHEKUP KIT | Healthkit | 1981-05-08 | Traditional | PDF ↗ |
| K800433 | HELENA COLOCHECK | Helena Laboratories | 1980-05-02 | Traditional | PDF ↗ |
| K792655 | HELENA COLOSCREEN | Helena Laboratories | 1980-01-24 | Traditional | PDF ↗ |
| K780564 | FECATEST | Otto C. Watzka | 1978-06-30 | Traditional | PDF ↗ |
| K780214 | HEMO FEC | Boehringer Mannheim Corp. | 1978-05-03 | Traditional | PDF ↗ |
| K770153 | CAMCO R PAK-GUAIAC | Cambridge Chemical Products, Inc. | 1977-02-08 | Traditional | PDF ↗ |
| K761232 | QUICK CULT SLIDE TEST FECAL OCCULT BLOOD | Laboratory Diagnostics Co., Inc. | 1976-12-21 | Traditional | PDF ↗ |
Product code KHE · Class II · Hematology. Data: openFDA.