OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
FDA 510(k) clearance K121397 · decided 2012-12-28
Clearance details
- K-number
- K121397
- Device name
- OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
- Applicant
- SEKISUI Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-05-09
- Decision date
- 2012-12-28
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- KHE
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
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| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.