IMDX FLU A/B AND RSV FOR ABBOTT M2000

Respiratory Virus Panel Nucleic Acid Assay System

INTELLIGENT MEDICAL DEVICES, INC

The following data is part of a premarket notification filed by Intelligent Medical Devices, Inc with the FDA for Imdx Flu A/b And Rsv For Abbott M2000.

Pre-market Notification Details

Device IDK131584
510k NumberK131584
Device Name:IMDX FLU A/B AND RSV FOR ABBOTT M2000
ClassificationRespiratory Virus Panel Nucleic Acid Assay System
Applicant INTELLIGENT MEDICAL DEVICES, INC 180 CABOT ST. Beverly,  MA  01915
ContactFran White
CorrespondentFran White
INTELLIGENT MEDICAL DEVICES, INC 180 CABOT ST. Beverly,  MA  01915
Product CodeOCC  
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-31
Decision Date2013-08-21
Summary:summary

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