Automated Blood Grouping And Antibody Test Systems

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 Automated Blood Grouping And Antibody Test Systems.

Pre-market Notification Details

Device IDBK170135
510k NumberBK170135
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Immucor, Inc. 3130 Gateway Drive Norcross,  GA  30071 US
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-23
Decision Date2018-04-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888234002338 BK170135 0

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