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FDA 510(k)

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT

K-Number: K043476 · 2005-02-15

ApplicantDade Behring, Inc.
Decision Date2005-02-15
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2005-02-15 under 510(k) number K043476. 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 STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT?

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT is a medical device that received FDA 510(k) clearance on 2005-02-15. The listed applicant is Dade Behring, Inc.. The 510(k) number is K043476.

When did STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT receive FDA 510(k) clearance?

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT received FDA 510(k) clearance on 2005-02-15, under 510(k) number K043476.

Who is the listed applicant for STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT?

The FDA product code for STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT is NBC.

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Related Devices (Code: NBC)

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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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