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Blood Establishment Computer Software And Accessories

Blood Bank Computer Systems, Inc.

The following data is part of a premarket notification filed by Blood Bank Computer Systems, 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 IDBK140184
510k NumberBK140184
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 Blood Bank Computer Systems, Inc. 1002 15th St. Sw, Suite 120 Auburn,  WA  98001
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-07
Decision Date2014-12-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860009119437 BK140184 0

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