FDA Product Code PMY: System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony
To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Isolated Bacterial Colonies Using Nucleic Acid Amplification Technology.
Leading manufacturers include Genepoc, Inc. and Opgen, Inc..
3
Total
3
Cleared
379d
Avg days
2016
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony Devices (Product Code PMY)
3 devices
Cleared
Sep 30, 2021
Acuitas AMR Gene Panel
Opgen, Inc.
Microbiology
871d
Cleared
May 10, 2019
GenePOC Carba
Genepoc, Inc.
Microbiology
91d
About Product Code PMY - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PMY since 2016, with 3 receiving FDA clearance (average review time: 379 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.