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FDA 510(k)

Acuitas AMR Gene Panel

K-Number: K191288 · 2021-09-30

ApplicantOpgen, Inc.
Decision Date2021-09-30
Product CodePMY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Acuitas AMR Gene Panel is a medical device manufactured by Opgen, Inc.. It received FDA 510(k) clearance on 2021-09-30 under approval number K191288. 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 Acuitas AMR Gene Panel?

Acuitas AMR Gene Panel is a medical device that received FDA 510(k) clearance on 2021-09-30. It is manufactured by Opgen, Inc.. The 510(k) number is K191288.

When was Acuitas AMR Gene Panel approved by the FDA?

Acuitas AMR Gene Panel received FDA 510(k) clearance on 2021-09-30, under approval number K191288.

What company makes Acuitas AMR Gene Panel?

Acuitas AMR Gene Panel is manufactured by Opgen, Inc..

What is the FDA product code for Acuitas AMR Gene Panel?

The FDA product code for Acuitas AMR Gene Panel is PMY.

Related Devices (Code: PMY)

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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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