VITEK MS

System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

BIOMERIEUX, INC.

The following data is part of a De Novo classification by Biomerieux, Inc. with the FDA for Vitek Ms.

Pre-market Notification Details

DeNovo IDDEN130013
Device Name:VITEK MS
ClassificationSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Applicant BIOMERIEUX, INC. 595 Anglum Rd. Hazelwood,  MO  63042
ContactNancy Weaver
Product CodePEX  
CFR Regulation Number866.3361 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK124067
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypeDirect
Date Received2013-01-02
Decision Date2013-08-21
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026362843 DEN130013 000
03573026359096 DEN130013 000
03573026359119 DEN130013 000

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