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510(k) K191288

Device
Acuitas AMR Gene Panel
Applicant
OpGen, Inc.
510(k) number
K191288
Product code
PMY  
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-30
Date received
2019-05-13
Regulation
866.1640
Classification name
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Autumn Collasius
Address
9717 Key W. Ave. Suite 100 Rockville MD US 20850 20850

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PMY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K190275GenePOC CarbaGenepoc, Inc.2019-05-10
K152614Xpert Carba-RCepheid2016-03-07

Legacy Summary#

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FDA Review#

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