HYDRASHIFT 2/4 daratumumab, daratumumab Control
K-Number: K172195 · 2018-01-11
ApplicantSebia
Decision Date2018-01-11
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
HYDRASHIFT 2/4 daratumumab, daratumumab Control is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2018-01-11 under approval number K172195. 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, daratumumab Control?
HYDRASHIFT 2/4 daratumumab, daratumumab Control is a medical device that received FDA 510(k) clearance on 2018-01-11. It is manufactured by Sebia. The 510(k) number is K172195.
When was HYDRASHIFT 2/4 daratumumab, daratumumab Control approved by the FDA?
HYDRASHIFT 2/4 daratumumab, daratumumab Control received FDA 510(k) clearance on 2018-01-11, under approval number K172195.
What company makes HYDRASHIFT 2/4 daratumumab, daratumumab Control?
HYDRASHIFT 2/4 daratumumab, daratumumab Control is manufactured by Sebia.
What is the FDA product code for HYDRASHIFT 2/4 daratumumab, daratumumab Control?
The FDA product code for HYDRASHIFT 2/4 daratumumab, daratumumab Control 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.