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FDA 510(k)

ELECSYS PROBNP IMMUNOASSAY

K-Number: K051382 · 2005-12-05

ApplicantRoche Diagnostics Corp.
Decision Date2005-12-05
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS PROBNP IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2005-12-05 under 510(k) number K051382. 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 IMMUNOASSAY?

ELECSYS PROBNP IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2005-12-05. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K051382.

When did ELECSYS PROBNP IMMUNOASSAY receive FDA 510(k) clearance?

ELECSYS PROBNP IMMUNOASSAY received FDA 510(k) clearance on 2005-12-05, under 510(k) number K051382.

Who is the listed applicant for ELECSYS PROBNP IMMUNOASSAY?

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

What is the FDA product code for ELECSYS PROBNP IMMUNOASSAY?

The FDA product code for ELECSYS PROBNP IMMUNOASSAY is NBC.

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Other records listing Roche Diagnostics Corp. as applicant

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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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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