# Control, Fecal Occult Blood
> **Product code: OSL** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.6550
## Classification
- **FDA Product Code:** OSL
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.6550
- **Review panel:** HE
- **Medical specialty:** Hematology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 8
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OSL)
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