Cleared Traditional

IMDX VANR FOR ABBOTT M2000

K123753 · Intelligent Medical Devices, Inc. · Microbiology
Jul 2013
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K123753 is an FDA 510(k) clearance for the IMDX VANR FOR ABBOTT M2000, a System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (Class II — Special Controls, product code NIJ), submitted by Intelligent Medical Devices, Inc. (Beverly, US). The FDA issued a Cleared decision on July 17, 2013, 223 days after receiving the submission on December 6, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K123753 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2012
Decision Date July 17, 2013
Days to Decision 223 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code NIJ — System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640
Definition The In Vitro Device Is Intended To Detect The Presence Of The Vana And Vanb Genes In Isolated Colonies Of Enterococcus Spp. As A Marker For Vancomycin Resistance Using Dna Probe Technology