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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nucleic acid amplification test, dna, carbapenem non-susceptible gram negative organism, colony
510(k) Number K191288
Device Name Acuitas AMR Gene Panel
Applicant
OpGen, Inc.
9717 Key West Avenue
Suite 100
Rockville,  MD  20850
Applicant Contact Autumn Collasius
Correspondent
Hogan Lovells, US LLP
Columbia Square
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number866.1640
Classification Product Code
PMY  
Subsequent Product Code
OOI  
Date Received05/13/2019
Decision Date 09/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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