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FDA 510(k)

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000

K-Number: K010266 · 2001-03-16

ApplicantBiosite Incorporated
Decision Date2001-03-16
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2001-03-16 under 510(k) number K010266. 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 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000?

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 is a medical device that received FDA 510(k) clearance on 2001-03-16. The listed applicant is Biosite Incorporated. The 510(k) number is K010266.

When did TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 receive FDA 510(k) clearance?

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 received FDA 510(k) clearance on 2001-03-16, under 510(k) number K010266.

Who is the listed applicant for TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000?

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

What is the FDA product code for TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000?

The FDA product code for TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 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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