Product code OSL
- Device name
- Control, Fecal Occult Blood
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.6550
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
- Source
- FDA openFDA device classification dataset