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FDA 510(k)

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

K-Number: K201312 · 2021-10-04

ApplicantOrtho Clinical Diagnostics
Decision Date2021-10-04
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack is a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2021-10-04 under approval number K201312. 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 VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack?

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack is a medical device that received FDA 510(k) clearance on 2021-10-04. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K201312.

When was VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack approved by the FDA?

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack received FDA 510(k) clearance on 2021-10-04, under approval number K201312.

What company makes VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack?

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack is manufactured by Ortho Clinical Diagnostics.

What is the FDA product code for VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack is NBC.

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Related Devices (Code: NBC)

K192380ST AIA-PACK BNPFujirebio Diagnostics,Inc. K211199ST AIA-PACK BNP AssayTosoh Bioscience, Inc. K210546Elecsys proBNP II, Elecsys proBNP II STATRoche 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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