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FDA 510(k)

Lumipulse G CA19-9-N

K-Number: K200997 · 2020-05-14

ApplicantFujirebio Diagnostics,Inc.
Decision Date2020-05-14
Product CodeNIG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Lumipulse G CA19-9-N 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 2020-05-14 under 510(k) number K200997. The device is classified under product code NIG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumipulse G CA19-9-N?

Lumipulse G CA19-9-N is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K200997.

When did Lumipulse G CA19-9-N receive FDA 510(k) clearance?

Lumipulse G CA19-9-N received FDA 510(k) clearance on 2020-05-14, under 510(k) number K200997.

Who is the listed applicant for Lumipulse G CA19-9-N?

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 CA19-9-N?

The FDA product code for Lumipulse G CA19-9-N is NIG.

Other records listing Fujirebio Diagnostics,Inc. as applicant

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Related Devices (Code: NIG)

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.

K253528Atellica IM CA 19-9 IISiemens Healthcare Diagnostics, Inc.K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackOrtho Clinical DiagnosticsK191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.

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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