Acuitas AMR Gene Panel— 510(k) K191288

Substantially Equivalent

Opgen, Inc.

FDA 510(k) clearance K191288 for Acuitas AMR Gene Panel, Substantially Equivalent on 2021-09-30. Applicant: Opgen, Inc..

Clearance details

Applicant: Opgen, Inc.
Product code: Code PMY
Advisory panel: Microbiology
Date received: 2019-05-13
Decision date: 2021-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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