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FDA 510(k)

IMMUNOCARD C. DIFFICILE GDH

K-Number: K112048 · 2011-12-16

ApplicantMeridian Bioscience, Inc.
Decision Date2011-12-16
Product CodeMCB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOCARD C. DIFFICILE GDH is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K112048. 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 IMMUNOCARD C. DIFFICILE GDH?

IMMUNOCARD C. DIFFICILE GDH is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K112048.

When did IMMUNOCARD C. DIFFICILE GDH receive FDA 510(k) clearance?

IMMUNOCARD C. DIFFICILE GDH received FDA 510(k) clearance on 2011-12-16, under 510(k) number K112048.

Who is the listed applicant for IMMUNOCARD C. DIFFICILE GDH?

The FDA 510(k) record lists Meridian Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOCARD C. DIFFICILE GDH?

The FDA product code for IMMUNOCARD C. DIFFICILE GDH is MCB.

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Other records listing Meridian Bioscience, Inc. as applicant

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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.K110620PREMIER C. DIFFICILE GDHMeridian Bioscience, Inc.K053572C. DIFF QUIK CHEKTechlab, Inc.K974881TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN ABiosite IncorporatedK955067CLEARVIEW 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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