← FDA Medical Device Classifications
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
DEM · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5130
Classification
- FDA Product Code
DEM- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.5130
- 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
- 30
- Registered establishments
- 24
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown