QMS Plazomicin Immunoassay

Plazomicin Test System, Immunoassay

Microgenics Corporation

The following data is part of a De Novo classification by Microgenics Corporation with the FDA for Qms Plazomicin Immunoassay.

Pre-market Notification Details

DeNovo IDDEN180030
Device Name:QMS Plazomicin Immunoassay
ClassificationPlazomicin Test System, Immunoassay
Applicant Microgenics Corporation 46500 Kato Road Fremont,  CA  94538
ContactMinoti Patel
Product CodeQDR  
CFR Regulation Number862.3460 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardToxicology
Classification AdvisoryToxicology
TypeDirect
Date Received2018-06-25
Decision Date2018-11-19
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883006966 DEN180030 000

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