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FDA 510(k)

TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300

K-Number: K042723 · 2004-12-07

ApplicantBiosite Incorporated
Decision Date2004-12-07
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2004-12-07 under 510(k) number K042723. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300?

TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 is a medical device that received FDA 510(k) clearance on 2004-12-07. The listed applicant is Biosite Incorporated. The 510(k) number is K042723.

When did TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 receive FDA 510(k) clearance?

TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 received FDA 510(k) clearance on 2004-12-07, under 510(k) number K042723.

Who is the listed applicant for TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300?

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 TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300?

The FDA product code for TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 is DAP.

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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: DAP)

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.

K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbHK172903HemosIL D-Dimer HS 500Instrumentation Laboratory COK162227STA® - Liatest® D-DiDiagnostica StagoK160885HemosIL D-Dimer HSInstrumentation Laboratory COK112818VIDAS D-DIMER EXCLUSION II (DEX2)bioMerieux, Inc.K110303STRATUS CS ACUTE CARE D-DIMERSiemens Healthcare Diagnostics

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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