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FDA 510(k)

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

K-Number: K024017 · 2003-01-30

ApplicantBayer Corp.
Decision Date2003-01-30
Product CodeNCW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BAYER ADVIA CENTAUR HER-2/NEU ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 2003-01-30 under 510(k) number K024017. The device is classified under product code NCW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER ADVIA CENTAUR HER-2/NEU ASSAY?

BAYER ADVIA CENTAUR HER-2/NEU ASSAY is a medical device that received FDA 510(k) clearance on 2003-01-30. The listed applicant is Bayer Corp.. The 510(k) number is K024017.

When did BAYER ADVIA CENTAUR HER-2/NEU ASSAY receive FDA 510(k) clearance?

BAYER ADVIA CENTAUR HER-2/NEU ASSAY received FDA 510(k) clearance on 2003-01-30, under 510(k) number K024017.

Who is the listed applicant for BAYER ADVIA CENTAUR HER-2/NEU ASSAY?

The FDA 510(k) record lists Bayer Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAYER ADVIA CENTAUR HER-2/NEU ASSAY?

The FDA product code for BAYER ADVIA CENTAUR HER-2/NEU ASSAY is NCW.

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Other records listing Bayer Corp. as applicant

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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEMK020828CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM

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Related Devices (Code: NCW)

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.

K992228BAYER IMMUNO 1 HER-2/NEU ASSAYBayer Corp.K994112MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)Oncogene Science, 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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