Automated Bloodborne Pathogen Test Equipment

Test, Equipment, Automated Bloodborne Pathogen

Siemens Healthcare Diagnostics, Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Automated Bloodborne Pathogen Test Equipment.

Pre-market Notification Details

Device IDBK140152
510k NumberBK140152
Device Name:Automated Bloodborne Pathogen Test Equipment
ClassificationTest, Equipment, Automated Bloodborne Pathogen
Applicant Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown,  NY  10591
Product CodeMZA  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-18
Decision Date2015-06-08

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