← FDA Medical Device Classifications
Reagent, Immunoassay, Igg
KTO · Class I — Low Risk (general controls) · Immunology · 21 CFR 866.5530
Classification
- FDA Product Code
KTO- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 866.5530
- Review panel
- IM
- Medical specialty
- Immunology
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 3
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown