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FDA 510(k)

Elecsys proBNP II, Elecsys proBNP II STAT

K-Number: K223637 · 2023-07-21

ApplicantRoche Diagnostics
Decision Date2023-07-21
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys proBNP II, Elecsys proBNP II STAT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2023-07-21 under 510(k) number K223637. 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 Elecsys proBNP II, Elecsys proBNP II STAT?

Elecsys proBNP II, Elecsys proBNP II STAT is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Roche Diagnostics. The 510(k) number is K223637.

When did Elecsys proBNP II, Elecsys proBNP II STAT receive FDA 510(k) clearance?

Elecsys proBNP II, Elecsys proBNP II STAT received FDA 510(k) clearance on 2023-07-21, under 510(k) number K223637.

Who is the listed applicant for Elecsys proBNP II, Elecsys proBNP II STAT?

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

What is the FDA product code for Elecsys proBNP II, Elecsys proBNP II STAT?

The FDA product code for Elecsys proBNP II, Elecsys proBNP II STAT is NBC.

Other records listing Roche Diagnostics as applicant

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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.

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.K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics

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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