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 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
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.
PMY devices are reviewed by the Microbiology panel. Browse all Microbiology devices →