Acuitas AMR Gene Panel

System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony

OpGen, Inc.

The following data is part of a premarket notification filed by Opgen, Inc. with the FDA for Acuitas Amr Gene Panel.

Pre-market Notification Details

Device IDK191288
510k NumberK191288
Device Name:Acuitas AMR Gene Panel
ClassificationSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony
Applicant OpGen, Inc. 9717 Key West Avenue Suite 100 Rockville,  MD  20850
ContactAutumn Collasius
CorrespondentRandy Prebula
Hogan Lovells, US LLP Columbia Square 555 Thirteenth Street, NW Washington,  DC  20004
Product CodePMY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-13
Decision Date2021-09-30

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