KZK
- Product code
- KZK
- Device name
- Reader, Zone, Automated
- Device class
- Class 1
- 21 CFR
- 21 CFR 866.2850
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
Official FDA classification page: KZK
Classification and pathway per current FDA publications. Data from openFDA (CC0).