FDA 510(k)

Lumipulse G CA19-9-N

K-Number: K200997 · 2020-05-14

Decision Date2020-05-14

Product CodeNIG

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Lumipulse G CA19-9-N is a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2020-05-14 under approval 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. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K200997.

When was Lumipulse G CA19-9-N approved by the FDA?

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

What company makes Lumipulse G CA19-9-N?

Lumipulse G CA19-9-N is manufactured by Fujirebio Diagnostics,Inc..

What is the FDA product code for Lumipulse G CA19-9-N?

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

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Related Devices (Code: NIG)

K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc. K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackOrtho Clinical 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.