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FDA 510(k)

VITROS CA 19-9

K-Number: K052889 · 2005-12-20

ApplicantFujirebio Diagnostics,Inc.
Decision Date2005-12-20
Product CodeNIG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VITROS CA 19-9 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 2005-12-20 under 510(k) number K052889. 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 VITROS CA 19-9?

VITROS CA 19-9 is a medical device that received FDA 510(k) clearance on 2005-12-20. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K052889.

When did VITROS CA 19-9 receive FDA 510(k) clearance?

VITROS CA 19-9 received FDA 510(k) clearance on 2005-12-20, under 510(k) number K052889.

Who is the listed applicant for VITROS CA 19-9?

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 VITROS CA 19-9?

The FDA product code for VITROS CA 19-9 is NIG.

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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 DiagnosticsK200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc.K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.K100375DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604Siemens Healthcare Diagnostics, Inc.K052000ARCHITECT CA 19-9XR ASSAYFujirebio 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.

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