OOX
6 FDA 510(k) clearances · Product code
264 daysmedian time to decision
801 days90th percentile
6clearances measured
FDA profile
- Official device name
- Automated Occult Blood Analyzer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6550
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- FDA definition
- The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Hemosure Accu-Reader A100 (K200754) | W.H.P.M., Inc. | 2022-06-02 |
| OC-Auto SENSOR io iFOB Test (K191147) | Eiken Chemical Co., Ltd. | 2020-01-02 |
| AFIAS iFOB with AFIAS-50 (K163225) | Immunostics Inc., | 2017-08-08 |
| I-CHROMA IFOB WITH I-CHROMA READER (K132167) | Boditech Med, Inc. | 2014-05-02 |
| OC-SENSOR DIANA IFOB TEST (K092330) | Polymedco Cancer Diagnostics, LLC | 2010-01-08 |
| POLYMEDCO OC AUTO MICRO 80 FOB TEST (K041408) | Polymedco, Inc. | 2004-10-21 |
Track OOX automatically
Every clearance here is in the API, with alerts when new ones post.