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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 the device name listed in this FDA 510(k) record. The listed applicant is Opgen, Inc.. It received FDA 510(k) clearance on 2021-09-30 under 510(k) 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. The listed applicant is Opgen, Inc.. The 510(k) number is K191288.

When did Acuitas AMR Gene Panel receive FDA 510(k) clearance?

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

Who is the listed applicant for Acuitas AMR Gene Panel?

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

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)

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.

K190275GenePOC CarbaGenepoc, Inc.K152614Xpert Carba-RCepheid

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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