KTN
- Product code
- KTN
- Device name
- System, Test, Infectious Mononucleosis
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5640
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (all years, FDA)
- 59 (all years; only the last 3 years are listed here)
Official FDA classification page: KTN
Classification and pathway per current FDA publications. Data from openFDA (CC0).