FDA 510(k)

Lumpipulse G CA19-9-N

K-Number: K191973 · 2019-10-22

Decision Date2019-10-22

Product CodeNIG

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Lumpipulse G CA19-9-N is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Dianostics, Inc.. It received FDA 510(k) clearance on 2019-10-22 under 510(k) 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. The listed applicant is Fujirebio Dianostics, Inc.. The 510(k) number is K191973.

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

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

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

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

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)

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 Diagnostics K200997Lumipulse G CA19-9-NFujirebio Diagnostics,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.