Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Automated Blood Grouping And Antibody Test Systems.

Pre-market Notification Details

Device IDBK190338
510k NumberBK190338
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 p.o. Box 350 Raritan,  NJ  08869
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-01
Decision Date2019-07-09

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