System, Test, Automated Blood Grouping And Antibody

System, Test, Automated Blood Grouping And Antibody

Immucor, Inc.

The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for System, Test, Automated Blood Grouping And Antibody.

Pre-market Notification Details

Device IDBK210605
510k NumberBK210605
Device Name:System, Test, Automated Blood Grouping And Antibody
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Immucor, Inc. 3130 Gateway Drive Norcross,  GA  30071
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-14
Decision Date2021-09-03

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