HYDRASHIFT 2/4 daratumumab
K-Number: K190851 · 2019-05-02
ApplicantSebia
Decision Date2019-05-02
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
HYDRASHIFT 2/4 daratumumab is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2019-05-02 under approval number K190851. 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 daratumumab?
HYDRASHIFT 2/4 daratumumab is a medical device that received FDA 510(k) clearance on 2019-05-02. It is manufactured by Sebia. The 510(k) number is K190851.
When was HYDRASHIFT 2/4 daratumumab approved by the FDA?
HYDRASHIFT 2/4 daratumumab received FDA 510(k) clearance on 2019-05-02, under approval number K190851.
What company makes HYDRASHIFT 2/4 daratumumab?
HYDRASHIFT 2/4 daratumumab is manufactured by Sebia.
What is the FDA product code for HYDRASHIFT 2/4 daratumumab?
The FDA product code for HYDRASHIFT 2/4 daratumumab 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.