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510(k) K191288

Acuitas AMR Gene Panel by Opgen, Inc. — Product Code PMY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2021
Date Received
May 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology.

Other clearances for product code PMY

  • K190275 — GenePOC Carba (May 10, 2019)
  • K152614 — Xpert Carba-R (March 7, 2016)