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FDA 510(k)

XPERT C. DIFFICILE

K-Number: K091109 · 2009-07-09

ApplicantCepheid
Decision Date2009-07-09
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XPERT C. DIFFICILE is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2009-07-09 under 510(k) number K091109. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPERT C. DIFFICILE?

XPERT C. DIFFICILE is a medical device that received FDA 510(k) clearance on 2009-07-09. The listed applicant is Cepheid. The 510(k) number is K091109.

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

XPERT C. DIFFICILE received FDA 510(k) clearance on 2009-07-09, under 510(k) number K091109.

Who is the listed applicant for XPERT C. DIFFICILE?

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. DIFFICILE?

The FDA product code for XPERT C. DIFFICILE is LLH.

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Other records listing Cepheid 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.

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

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Related Devices (Code: LLH)

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.

K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.K102242OSOM C. DIFFICILE TOXIN A/B TESTGenzyme CorporationK090239PROGASTRO CD ASSAYProdesse, Inc.K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, Inc.)K080931VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAYbioMerieux, 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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