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FDA 510(k)

Cepheid Xpert C. difficile/Epi Control Panel

K-Number: K190463 · 2019-04-19

ApplicantMicrobiologics, Inc.
Decision Date2019-04-19
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Cepheid Xpert C. difficile/Epi Control Panel is a medical device manufactured by Microbiologics, Inc.. It received FDA 510(k) clearance on 2019-04-19 under approval number K190463. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cepheid Xpert C. difficile/Epi Control Panel?

Cepheid Xpert C. difficile/Epi Control Panel is a medical device that received FDA 510(k) clearance on 2019-04-19. It is manufactured by Microbiologics, Inc.. The 510(k) number is K190463.

When was Cepheid Xpert C. difficile/Epi Control Panel approved by the FDA?

Cepheid Xpert C. difficile/Epi Control Panel received FDA 510(k) clearance on 2019-04-19, under approval number K190463.

What company makes Cepheid Xpert C. difficile/Epi Control Panel?

Cepheid Xpert C. difficile/Epi Control Panel is manufactured by Microbiologics, Inc..

What is the FDA product code for Cepheid Xpert C. difficile/Epi Control Panel?

The FDA product code for Cepheid Xpert C. difficile/Epi Control Panel is PMN.

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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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