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FDA 510(k)

Lumipulse G CA15-3

K-Number: K192524 · 2020-09-04

ApplicantFujirebio Diagnostics,Inc.
Decision Date2020-09-04
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Lumipulse G CA15-3 is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K192524. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumipulse G CA15-3?

Lumipulse G CA15-3 is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K192524.

When did Lumipulse G CA15-3 receive FDA 510(k) clearance?

Lumipulse G CA15-3 received FDA 510(k) clearance on 2020-09-04, under 510(k) number K192524.

Who is the listed applicant for Lumipulse G CA15-3?

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

What is the FDA product code for Lumipulse G CA15-3?

The FDA product code for Lumipulse G CA15-3 is MOI.

Other records listing Fujirebio Diagnostics,Inc. as applicant

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Related Devices (Code: MOI)

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.

K240403Access BR MonitorBeckman Coulter, Inc.K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.K181492Elecsys CA 15-3 IIRoche DiagnosticsK171605Elecsys CA 15-3 IIRoche Diagnostics

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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