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FDA 510(k)

TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A

K-Number: K974881 · 1998-03-20

ApplicantBiosite Incorporated
Decision Date1998-03-20
Product CodeMCB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 1998-03-20 under 510(k) number K974881. The device is classified under product code MCB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A?

TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A is a medical device that received FDA 510(k) clearance on 1998-03-20. The listed applicant is Biosite Incorporated. The 510(k) number is K974881.

When did TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A receive FDA 510(k) clearance?

TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A received FDA 510(k) clearance on 1998-03-20, under 510(k) number K974881.

Who is the listed applicant for TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A?

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 C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A?

The FDA product code for TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A is MCB.

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Other records listing Biosite Incorporated as applicant

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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: MCB)

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.

K132010VIDAS C DIFFICILE GDHBiomerieux S.A.K112048IMMUNOCARD C. DIFFICILE GDHMeridian Bioscience, Inc.K110620PREMIER C. DIFFICILE GDHMeridian Bioscience, Inc.K053572C. DIFF QUIK CHEKTechlab, Inc.K955067CLEARVIEW C. DIFF AUnipath , Ltd.K924062MERITEC C. DIFFICILE CONTROLSMeridian 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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