Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-