← FDA Medical Device Classifications
Control, Fecal Occult Blood
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
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown