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FDA 510(k)

ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

K-Number: K031038 · 2003-06-23

ApplicantBayer Healthcare, LLC
Decision Date2003-06-23
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2003-06-23 under 510(k) number K031038. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY?

ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY is a medical device that received FDA 510(k) clearance on 2003-06-23. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K031038.

When did ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY receive FDA 510(k) clearance?

ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY received FDA 510(k) clearance on 2003-06-23, under 510(k) number K031038.

Who is the listed applicant for ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY?

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

What is the FDA product code for ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY?

The FDA product code for ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY is NBC.

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Related Devices (Code: NBC)

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.

K262109Access NT-proBNPBeckman Coulter, Inc.K252169Access BNP IIBeckman Coulter, Inc.K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd.K232164Access NT-proBNPBeckman Coulter, Inc.K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare 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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