KHE — Reagent, Occult Blood Class II
FDA product code KHE covers "Reagent, Occult Blood", a Class II medical device regulated under 21 CFR 864.6550. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KHE
- Device Class
- Class II
- Regulation Number
- 864.6550
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K173212 | alfa scientific designs | Instant-view-PLUS immunochemical Fecal Occult Blood Test | February 15, 2018 |
| K170548 | enterix | InSure ONE | October 5, 2017 |
| K171484 | immunostics inc | hema-screen SPECIFIC Gold | June 14, 2017 |
| K162333 | guangzhou wondfo biotech co | Wondfo One Step Fecal Occult Blood (FOB) Test | May 14, 2017 |
| K163554 | immunostics inc | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | January 17, 2017 |
| K143325 | eiken chemical co | OC-Light S FIT | August 20, 2015 |
| K121397 | sekisui diagnostics | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 | December 28, 2012 |
| K113506 | ind diagnostics | IND ONE STEP OCCULT BLOOD (FOB) TEST | December 19, 2012 |
| K110309 | orient gene biotech | FOB ONE STEP RAPID TEST | September 14, 2011 |
| K102664 | immunostics inc | HEMA SCREEN ER | January 28, 2011 |
| K100031 | ind diagnostic | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | July 19, 2010 |
| K100817 | princeton biomeditech | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | July 1, 2010 |
| K080812 | beckman coulter | HEMOCCULT ICT | June 25, 2008 |
| K071242 | ameritek usa | DBEST ONE STEP OCCULT BLOOD TEST KITS | March 6, 2008 |
| K073431 | tianjin new bay bioresearch co | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HO | January 14, 2008 |
| K070660 | alfa scientific designs | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | June 21, 2007 |
| K063693 | new bay bioresearch co. | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST | May 11, 2007 |
| K063673 | innovacon | INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE | March 5, 2007 |
| K060953 | yd diagnostics | OCCULTECH FECAL OCCULT BLOOD RAPID TEST | September 18, 2006 |
| K061065 | teco diagnostics | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F | July 14, 2006 |