← FDA Medical Device Classifications
System, Test, Rheumatoid Factor
DHR · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5775
Classification
- FDA Product Code
DHR- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.5775
- Review panel
- IM
- Medical specialty
- Immunology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 144
- Registered establishments
- 57
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown