Cobas VivoDx MRSA

Device 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 Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Device Classification Under Section 513(f)(2)(de Novo) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fd

Roche Molecular Systems, Inc.

The following data is part of a De Novo classification by Roche Molecular Systems, Inc. with the FDA for Cobas Vivodx Mrsa.

Pre-market Notification Details

DeNovo IDDEN190016
Device Name:Cobas VivoDx MRSA
ClassificationDevice 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 Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Device Classification Under Section 513(f)(2)(de Novo) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fd
Applicant Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton,  CA  94588 -2722
ContactNobuko Nakajima
Product CodeQIV
CFR Regulation NumberDevice Classification Under Section 513(f)(2)(de N [🔎]
DecisionGranted (DENG)
510(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 BoardMicrobiology
Classification AdvisoryDevice 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 Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Fo
TypeDirect
Date Received2019-03-19
Decision Date2019-12-05
Reclassification Order:Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336129487 DEN190016 000
00875197006193 DEN190016 000
00875197005820 DEN190016 000
00875197005813 DEN190016 000

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