Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

Diagnostic Grifols, S. A.

The following data is part of a premarket notification filed by Diagnostic Grifols, S. A. with the FDA for Automated Blood Grouping And Antibody Test Systems.

Pre-market Notification Details

Device IDBK200467
510k NumberBK200467
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Diagnostic Grifols, S. A. passeig Fluvial, 24 barcelona Parets Del Valles,  08150,  SP
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-10
Decision Date2020-04-23

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