ARIES System

Real Time Nucleic Acid Amplification System

LUMINEX CORPORATION

The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries System.

Pre-market Notification Details

Device IDK151917
510k NumberK151917
Device Name:ARIES System
ClassificationReal Time Nucleic Acid Amplification System
Applicant LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin,  TX  78727
ContactRonald Dunn
CorrespondentRonald Dunn
LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin,  TX  78727
Product CodeOOI  
CFR Regulation Number862.2570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-13
Decision Date2015-10-06

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