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FDA 510(k)

TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS

K-Number: K080269 · 2008-06-06

ApplicantBiosite Incorporated
Decision Date2008-06-06
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2008-06-06 under 510(k) number K080269. 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 CARDIOPROFILER AND PROFILER S.O.B. PANELS?

TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS is a medical device that received FDA 510(k) clearance on 2008-06-06. The listed applicant is Biosite Incorporated. The 510(k) number is K080269.

When did TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS receive FDA 510(k) clearance?

TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS received FDA 510(k) clearance on 2008-06-06, under 510(k) number K080269.

Who is the listed applicant for TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS?

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 CARDIOPROFILER AND PROFILER S.O.B. PANELS?

The FDA product code for TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS 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 SETK072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5K062840TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLSK062530TRIAGE PROTEIN C TEST

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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.

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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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