System, Test, Automated Blood Grouping And Antibody

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 System, Test, Automated Blood Grouping And Antibody.

Pre-market Notification Details

Device IDBK210557
510k NumberBK210557
Device Name:System, Test, Automated Blood Grouping And Antibody
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 Raritan,  NJ  08869 0606
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-23
Decision Date2021-05-13

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