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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2019-05-02 under 510(k) 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. The listed applicant is Sebia. The 510(k) number is K190851.

When did HYDRASHIFT 2/4 daratumumab receive FDA 510(k) clearance?

HYDRASHIFT 2/4 daratumumab received FDA 510(k) clearance on 2019-05-02, under 510(k) number K190851.

Who is the listed applicant for HYDRASHIFT 2/4 daratumumab?

The FDA 510(k) record lists Sebia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDRASHIFT 2/4 daratumumab?

The FDA product code for HYDRASHIFT 2/4 daratumumab is CFF.

Other records listing Sebia as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentK231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2K203184HYDRASHIFT 2/4 isatuximabK192095CAPI 3 Immunotyping, Capillarys 3 TeraK180762CAPI 3 HEMOGLOBIN(E)

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Related Devices (Code: CFF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203184HYDRASHIFT 2/4 isatuximabSebiaK192095CAPI 3 Immunotyping, Capillarys 3 TeraSebiaK172195HYDRASHIFT 2/4 daratumumab, daratumumab ControlSebiaK161928CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROLSebia

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.

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