Product code KHE
- Device name
- Reagent, Occult Blood
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.6550
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | 2018-02-15 |
| K170548 | InSure ONE | Enterix, Inc. | 2017-10-05 |
| K171484 | hema-screen SPECIFIC Gold | Immunostics Inc., | 2017-06-14 |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | Guangzhou Wondfo Biotech Co., Ltd. | 2017-05-14 |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | Immunostics Inc., | 2017-01-17 |
| K143325 | OC-Light S FIT | Eiken Chemical Co., Ltd. | 2015-08-20 |
| K121397 | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT | SEKISUI Diagnostics, LLC | 2012-12-28 |
| K113506 | IND ONE STEP OCCULT BLOOD (FOB) TEST | Ind Diagnostics, Inc. | 2012-12-19 |
| K110309 | FOB ONE STEP RAPID TEST | Orient Gene Biotech | 2011-09-14 |
| K102664 | HEMA SCREEN ER | Immunostics Inc., | 2011-01-28 |
| K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | Ind Diagnostic, Inc. | 2010-07-19 |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Princeton BioMeditech Corp. | 2010-07-01 |
| K080812 | HEMOCCULT ICT | Beckman Coulter, Inc. | 2008-06-25 |
| K071242 | DBEST ONE STEP OCCULT BLOOD TEST KITS | Ameritek USA, Inc. | 2008-03-06 |
| 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 |
| K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | Alfa Scientific Designs, Inc. | 2007-06-21 |
| K063693 | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST | New Bay Bioresearch Co. , Ltd. | 2007-05-11 |
| K063673 | INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE | Innovacon, Inc. | 2007-03-05 |
| K060953 | OCCULTECH FECAL OCCULT BLOOD RAPID TEST | Yd Diagnostics Corp. | 2006-09-18 |
| K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 | Teco Diagnostics | 2006-07-14 |
| K060463 | HEMA SCREEN SPECIFIC IFOBT | Immunostics Inc., | 2006-06-06 |
| K060930 | INSURE II | Enterix, Inc. | 2006-05-04 |
| K052598 | IMMOCARE | Care Diagnostic, Inc. | 2006-03-16 |
| K051806 | CARE FECAL OCCULT BLOOD TEST, MODEL KT313 | Epitope Diagnostics, Inc. | 2005-10-03 |
| K041297 | POLYMEDCO OC LIGHT FOBT TEST | Polymedco, Inc. | 2004-08-12 |
| K041202 | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST | W.H.P.M., Inc. | 2004-08-12 |
| K033548 | ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER | Roche Diagnostics Corp. | 2003-11-24 |
| K031356 | HEMAPROMPT GASTRIC | Aerscher Diagnostics | 2003-09-24 |
| K030216 | COLONCARE | Care Products, Inc. | 2003-04-02 |
| K022755 | LIFEGUARD | Medtek, LLC | 2002-09-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10722066011338 | Rapid Response | BTNX Inc | 2026-01-02 |
| 10722355003068 | hema-screen SPECIFIC GOLD | Immunostics Company, Inc | 2025-04-16 |
| 10722355002900 | hema-screen SPECIFIC GOLD | Immunostics Company, Inc | 2025-04-16 |
| 10722355002894 | hema-screen SPECIFIC GOLD | Immunostics Company, Inc | 2025-04-16 |
| 10722066007102 | Rapid Response | BTNX Inc | 2023-06-15 |
| 30080196165142 | Medline | MEDLINE INDUSTRIES, INC. | 2021-10-29 |
| 10304040054168 | Henry Schein | HENRY SCHEIN, INC. | 2017-11-14 |
| 10304040054175 | Henry Schein | HENRY SCHEIN, INC. | 2017-11-14 |
| M220P0800183 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| 00304040002544 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 00304040002537 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 00304040002520 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10722355001057 | hema-screen STAT | Immunostics Company, Inc | 2016-09-23 |
| 10722355001002 | hema-screen | Immunostics Company, Inc | 2016-09-23 |
| 10722355001019 | hema-screen | Immunostics Company, Inc | 2016-09-23 |
| 10722355001026 | hema-screen | Immunostics Company, Inc | 2016-09-23 |
| 10722355001033 | hema-screen | Immunostics Company, Inc | 2016-09-23 |
| 10743816001072 | Status iFOBTest Device Refill | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10722355001040 | hema-screen | Immunostics Company, Inc | 2016-09-23 |
| 10722355002740 | Early Discovery | Immunostics Company, Inc | 2016-09-23 |
| 10722355002559 | hema-screen ER developer | Immunostics Company, Inc | 2016-09-23 |
| 10722355002528 | hema-screen ER | Immunostics Company, Inc | 2016-09-23 |
| 10722355002504 | hema-screen ER | Immunostics Company, Inc | 2016-09-23 |
| 10722355002146 | hema-screen Triple 335 | Immunostics Company, Inc | 2016-09-23 |
| 10722355001125 | hema-screen | Immunostics Company, Inc | 2016-09-23 |
| 10722355001071 | hema-screen SPECIFIC | Immunostics Company, Inc | 2016-09-21 |
| 10722355001095 | hema-screen SPECIFIC | Immunostics Company, Inc | 2016-09-21 |
| 10722355001101 | hema-screen SPECIFIC | Immunostics Company, Inc | 2016-09-21 |
| M52550780 | ColoScreen Developer 2 | HELENA LABORATORIES CORPORATION | 2016-08-18 |
| M52550880 | ColoScreen-ES Developer-15 | HELENA LABORATORIES CORPORATION | 2016-08-18 |