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FDA 510(k)

GenePOC CDiff

K-Number: K172569 · 2017-11-22

ApplicantGenepoc, Inc.
Decision Date2017-11-22
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GenePOC CDiff is the device name listed in this FDA 510(k) record. The listed applicant is Genepoc, Inc.. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172569. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GenePOC CDiff?

GenePOC CDiff is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Genepoc, Inc.. The 510(k) number is K172569.

When did GenePOC CDiff receive FDA 510(k) clearance?

GenePOC CDiff received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172569.

Who is the listed applicant for GenePOC CDiff?

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

What is the FDA product code for GenePOC CDiff?

The FDA product code for GenePOC CDiff is OZN.

Other records listing Genepoc, 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: OZN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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