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FDA 510(k)

TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

K-Number: K030286 · 2003-02-21

ApplicantBiosite Incorporated
Decision Date2003-02-21
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2003-02-21 under 510(k) number K030286. 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 TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL?

TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL is a medical device that received FDA 510(k) clearance on 2003-02-21. The listed applicant is Biosite Incorporated. The 510(k) number is K030286.

When did TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL receive FDA 510(k) clearance?

TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL received FDA 510(k) clearance on 2003-02-21, under 510(k) number K030286.

Who is the listed applicant for TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL?

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

What is the FDA product code for TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL?

The FDA product code for TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL is NBC.

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Other records listing Biosite Incorporated 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.

K092987INRATIO/INRATIO2 TEST STRIPSK092048ONE STEP EDDP (METHADONE METABOLITE) TEST STRIPK093032TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SETK080269TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELSK072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5K062840TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS

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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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