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Blood Establishment Computer Software And Accessories

Grifols Diagnostic Solutions Inc.

The following data is part of a premarket notification filed by Grifols Diagnostic Solutions Inc. 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 IDBK140150
510k NumberBK140150
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
ClassificationBlood Establishment Computer Software And Accessories
Applicant Grifols Diagnostic Solutions Inc. 4560 Horton Street, M/s N-200 Emeryville,  CA  94608 US
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-11
Decision Date2014-08-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00866489000012 BK140150 0
00866489000005 BK140150 0

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