FDA 510(k)

GenePOC CDiff

K-Number: K172569 · 2017-11-22

Decision Date2017-11-22

Product CodeOZN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

GenePOC CDiff is a medical device manufactured by Genepoc, Inc.. It received FDA 510(k) clearance on 2017-11-22 under approval 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. It is manufactured by Genepoc, Inc.. The 510(k) number is K172569.

When was GenePOC CDiff approved by the FDA?

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

What company makes GenePOC CDiff?

GenePOC CDiff is manufactured by Genepoc, Inc..

What is the FDA product code for GenePOC CDiff?

The FDA product code for GenePOC CDiff is OZN.

Other Devices by Genepoc, Inc.

K170558revogene K170557GenePOC GBS LB K190275GenePOC Carba K183366GenePOC Strep A

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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.