HYDRASHIFT 2/4 isatuximab
K-Number: K203184 · 2021-11-12
ApplicantSebia
Decision Date2021-11-12
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
HYDRASHIFT 2/4 isatuximab is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2021-11-12 under approval number K203184. The device is classified under product code CFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HYDRASHIFT 2/4 isatuximab?
HYDRASHIFT 2/4 isatuximab is a medical device that received FDA 510(k) clearance on 2021-11-12. It is manufactured by Sebia. The 510(k) number is K203184.
When was HYDRASHIFT 2/4 isatuximab approved by the FDA?
HYDRASHIFT 2/4 isatuximab received FDA 510(k) clearance on 2021-11-12, under approval number K203184.
What company makes HYDRASHIFT 2/4 isatuximab?
HYDRASHIFT 2/4 isatuximab is manufactured by Sebia.
What is the FDA product code for HYDRASHIFT 2/4 isatuximab?
The FDA product code for HYDRASHIFT 2/4 isatuximab is CFF.
Other Devices by Sebia
Related Devices (Code: CFF)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.