# Automated Occult Blood Analyzer
> **Product code: OOX** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.6550
## Classification
- **FDA Product Code:** OOX
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.6550
- **Review panel:** HE
- **Medical specialty:** Hematology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 6
- **Registered establishments:** 16
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OOX)
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