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FDA 510(k)

Elecsys proBNP II, Elecsys proBNP II STAT

K-Number: K210546 · 2022-03-31

ApplicantRoche Diagnostics
Decision Date2022-03-31
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys proBNP II, Elecsys proBNP II STAT is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2022-03-31 under approval number K210546. 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 2022-03-31. It is manufactured by Roche Diagnostics. The 510(k) number is K210546.

When was Elecsys proBNP II, Elecsys proBNP II STAT approved by the FDA?

Elecsys proBNP II, Elecsys proBNP II STAT received FDA 510(k) clearance on 2022-03-31, under approval number K210546.

What company makes Elecsys proBNP II, Elecsys proBNP II STAT?

Elecsys proBNP II, Elecsys proBNP II STAT is manufactured by Roche Diagnostics.

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.

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Related Devices (Code: NBC)

K192380ST AIA-PACK BNPFujirebio Diagnostics,Inc. K211199ST AIA-PACK BNP AssayTosoh Bioscience, Inc. K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc. K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics K232164Access NT-proBNPBeckman Coulter, 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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