Cleared Traditional

GenePOC Carba

K190275 · Genepoc, Inc. · Microbiology
May 2019
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K190275 is an FDA 510(k) clearance for the GenePOC Carba, a System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony (Class II — Special Controls, product code PMY), submitted by Genepoc, Inc. (Quebec, CA). The FDA issued a Cleared decision on May 10, 2019, 91 days after receiving the submission on February 8, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K190275 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2019
Decision Date May 10, 2019
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PMY — System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640
Definition To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Isolated Bacterial Colonies Using Nucleic Acid Amplification Technology.