← FDA Medical Device Classifications
Immunoglobulin G Kappa Heavy And Light Chain Combined
PCN · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5510
Classification
- FDA Product Code
PCN- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.5510
- Review panel
- IM
- Medical specialty
- Immunology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
Intended for the in-vitro quantification of IgG kappa concentration in human serum.
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown