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510(k) K190275

GenePOC Carba by Genepoc, Inc. — Product Code PMY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2019
Date Received
February 8, 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 by Genepoc, Inc.

  • K183366 — GenePOC Strep A (March 6, 2019)
  • K172569 — GenePOC CDiff (November 22, 2017)
  • K170558 — revogene (May 25, 2017)
  • K170557 — GenePOC GBS LB (May 25, 2017)

Other clearances for product code PMY

  • K191288 — Acuitas AMR Gene Panel (September 30, 2021)
  • K152614 — Xpert Carba-R (March 7, 2016)