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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 the device name listed in this FDA 510(k) record. The listed applicant is Microbiologics, Inc.. It received FDA 510(k) clearance on 2019-04-19 under 510(k) 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. The listed applicant is Microbiologics, Inc.. The 510(k) number is K190463.

When did Cepheid Xpert C. difficile/Epi Control Panel receive FDA 510(k) clearance?

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

Who is the listed applicant for Cepheid Xpert C. difficile/Epi Control Panel?

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

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.

Other records listing Microbiologics, Inc. 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.

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Related Devices (Code: 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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