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FDA 510(k)

XPERT C. DIFFICLE/EPI ASSAY

K-Number: K110203 · 2011-04-07

ApplicantCepheid
Decision Date2011-04-07
Product CodeOMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XPERT C. DIFFICLE/EPI ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2011-04-07 under 510(k) number K110203. The device is classified under product code OMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPERT C. DIFFICLE/EPI ASSAY?

XPERT C. DIFFICLE/EPI ASSAY is a medical device that received FDA 510(k) clearance on 2011-04-07. The listed applicant is Cepheid. The 510(k) number is K110203.

When did XPERT C. DIFFICLE/EPI ASSAY receive FDA 510(k) clearance?

XPERT C. DIFFICLE/EPI ASSAY received FDA 510(k) clearance on 2011-04-07, under 510(k) number K110203.

Who is the listed applicant for XPERT C. DIFFICLE/EPI ASSAY?

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

What is the FDA product code for XPERT C. DIFFICLE/EPI ASSAY?

The FDA product code for XPERT C. DIFFICLE/EPI ASSAY is OMN.

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Other records listing Cepheid as applicant

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K261336Xpert Respiratory PanelK261362Xpert Hemorrhagic FeverK261867Xpert Carba-RK253653Xpert Hemorrhagic FeverK251721Xpert GI PanelK250996Xpert Xpress CoV-2/Flu/RSV plus

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Related Devices (Code: OMN)

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.

K113433SIMPLEXA C. DIFFICILE UNIVERSAL DIRECTFocus Diagnostics, Inc.K110012ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10Meridian Bioscience, Inc.K100818ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920Meridian Bioscience, 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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