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FDA 510(k)

Lumpipulse G CA19-9-N

K-Number: K191973 · 2019-10-22

ApplicantFujirebio Dianostics, Inc.
Decision Date2019-10-22
Product CodeNIG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Lumpipulse G CA19-9-N is a medical device manufactured by Fujirebio Dianostics, Inc.. It received FDA 510(k) clearance on 2019-10-22 under approval number K191973. 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 Lumpipulse G CA19-9-N?

Lumpipulse G CA19-9-N is a medical device that received FDA 510(k) clearance on 2019-10-22. It is manufactured by Fujirebio Dianostics, Inc.. The 510(k) number is K191973.

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

Lumpipulse G CA19-9-N received FDA 510(k) clearance on 2019-10-22, under approval number K191973.

What company makes Lumpipulse G CA19-9-N?

Lumpipulse G CA19-9-N is manufactured by Fujirebio Dianostics, Inc..

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

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

Related Devices (Code: NIG)

K200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc. K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackOrtho Clinical Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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