Blood Establishment Computer Software And Accessories

Blood Establishment Computer Software And Accessories

Diagnostic Grifols, S. A.

The following data is part of a premarket notification filed by Diagnostic Grifols, S. A. with the FDA for Blood Establishment Computer Software And Accessories.

Pre-market Notification Details

Device IDBK220744
510k NumberBK220744
Device Name:Blood Establishment Computer Software And Accessories
ClassificationBlood Establishment Computer Software And Accessories
Applicant Diagnostic Grifols, S. A. passeig Fluvial, 24 barcelona Parets Del Valles,  08150,  SPAIN
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-12
Decision Date2022-09-09

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