HYDRASHIFT 2/4 daratumumab, daratumumab Control— 510(k) K172195
Substantially EquivalentSebia
FDA 510(k) clearance K172195 for HYDRASHIFT 2/4 daratumumab, daratumumab Control, Substantially Equivalent on 2018-01-11. Applicant: Sebia.
Clearance details
- Applicant
- Sebia
- Product code
- Code CFF
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.