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Manual Blood Grouping And Antibody Test Systems

Diagnostic Grifols, S. A.

The following data is part of a premarket notification filed by Diagnostic Grifols, S. A. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK120045
510k NumberBK120045
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationManual Blood Grouping And Antibody Test Systems
Applicant Diagnostic Grifols, S. A. passeig Fluvial, 24 barcelona Parets Del Valles,  08150,  SP
Product CodePBC  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-05
Decision Date2013-07-19

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