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FDA 510(k)

GenePOC Carba

K-Number: K190275 · 2019-05-10

ApplicantGenepoc, Inc.
Decision Date2019-05-10
Product CodePMY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GenePOC Carba is a medical device manufactured by Genepoc, Inc.. It received FDA 510(k) clearance on 2019-05-10 under approval number K190275. The device is classified under product code PMY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GenePOC Carba?

GenePOC Carba is a medical device that received FDA 510(k) clearance on 2019-05-10. It is manufactured by Genepoc, Inc.. The 510(k) number is K190275.

When was GenePOC Carba approved by the FDA?

GenePOC Carba received FDA 510(k) clearance on 2019-05-10, under approval number K190275.

What company makes GenePOC Carba?

GenePOC Carba is manufactured by Genepoc, Inc..

What is the FDA product code for GenePOC Carba?

The FDA product code for GenePOC Carba is PMY.

Other Devices by Genepoc, Inc.

K172569GenePOC CDiff K170558revogene K170557GenePOC GBS LB K183366GenePOC Strep A

Related Devices (Code: PMY)

K152614Xpert Carba-RCepheid K191288Acuitas AMR Gene PanelOpgen, 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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