LKT
- Product code
- LKT
- Device name
- Respiratory Syncytial Virus, Antigen, Antibody, Ifa
- Device class
- Class 1
- 21 CFR
- 21 CFR 866.3480
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 23 (all years; only the last 3 years are listed here)
Official FDA classification page: LKT
Classification and pathway per current FDA publications. Data from openFDA (CC0).