OOX — Automated Occult Blood Analyzer Class II
FDA product code OOX covers "Automated Occult Blood Analyzer", a Class II medical device regulated under 21 CFR 864.6550. Submissions are reviewed by the Hematology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OOX
- Device Class
- Class II
- Regulation Number
- 864.6550
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K200754 | w.h.p.m | Hemosure Accu-Reader A100 | June 2, 2022 |
| K191147 | eiken chemical co | OC-Auto SENSOR io iFOB Test | January 2, 2020 |
| K163225 | immunostics inc | AFIAS iFOB with AFIAS-50 | August 8, 2017 |
| K132167 | boditech med | I-CHROMA IFOB WITH I-CHROMA READER | May 2, 2014 |
| K092330 | polymedco cancer diagnostics | OC-SENSOR DIANA IFOB TEST | January 8, 2010 |
| K041408 | polymedco | POLYMEDCO OC AUTO MICRO 80 FOB TEST | October 21, 2004 |