KEM
- Product code
- KEM
- Device name
- Agent, Clearing
- Device class
- Class 1
- 21 CFR
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Marketing pathway
- 510(K) Exempt
- Flag
- GMP exempt
- 510(k) clearances (last 3 years)
- 15
Official FDA classification page: KEM
Classification and pathway per current FDA publications. Data from openFDA (CC0).