Automated Bloodborne Pathogen Test Equipment

Test, Equipment, Automated Bloodborne Pathogen

Roche Molecular Systems, Inc.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Automated Bloodborne Pathogen Test Equipment.

Pre-market Notification Details

Device IDBK140195
510k NumberBK140195
Device Name:Automated Bloodborne Pathogen Test Equipment
ClassificationTest, Equipment, Automated Bloodborne Pathogen
Applicant Roche Molecular Systems, Inc. 4300 Hacienda Drive p.o. Box 9002 Pleasanton,,  CA  94588
Product CodeMZA  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-13
Decision Date2016-10-20

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