Automated Bloodborne Pathogen Test Equipment

Test, Equipment, Automated Bloodborne Pathogen

Ortho-Clinical Diagnostics, Inc.

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

Pre-market Notification Details

Device IDBK100061
510k NumberBK100061
Device Name:Automated Bloodborne Pathogen Test Equipment
ClassificationTest, Equipment, Automated Bloodborne Pathogen
Applicant Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 Raritan,  NJ  08869 US
Product CodeMZA  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-30
Decision Date2010-10-28

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