HYDRASHIFT 2/4 daratumumab— 510(k) K190851

Substantially Equivalent

Sebia

FDA 510(k) clearance K190851 for HYDRASHIFT 2/4 daratumumab, Substantially Equivalent on 2019-05-02. Applicant: Sebia.

Clearance details

Applicant: Sebia
Product code: Code CFF
Advisory panel: Immunology
Date received: 2019-04-02
Decision date: 2019-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Norcross, GA, US

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