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FDA 510(k)

BAYER IMMUNO 1 HER-2/NEU ASSAY

K-Number: K992228 · 2000-09-29

ApplicantBayer Corp.
Decision Date2000-09-29
Product CodeNCW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BAYER IMMUNO 1 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 2000-09-29 under 510(k) number K992228. 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 IMMUNO 1 HER-2/NEU ASSAY?

BAYER IMMUNO 1 HER-2/NEU ASSAY is a medical device that received FDA 510(k) clearance on 2000-09-29. The listed applicant is Bayer Corp.. The 510(k) number is K992228.

When did BAYER IMMUNO 1 HER-2/NEU ASSAY receive FDA 510(k) clearance?

BAYER IMMUNO 1 HER-2/NEU ASSAY received FDA 510(k) clearance on 2000-09-29, under 510(k) number K992228.

Who is the listed applicant for BAYER IMMUNO 1 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 IMMUNO 1 HER-2/NEU ASSAY?

The FDA product code for BAYER IMMUNO 1 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 TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE 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.

K024017BAYER ADVIA CENTAUR 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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