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 IDBK100001
510k NumberBK100001
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross,  GA  30091
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-15
Decision Date2010-04-29

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