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Blood Establishment Computer Software And Accessories

American Blood Resources Association

The following data is part of a premarket notification filed by American Blood Resources Association 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 IDBK010012
510k NumberBK010012
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 American Blood Resources Association 147 Old Solomons Island Rd. Annapolis,  MD  21401
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Abbrevia
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-21
Decision Date2001-09-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812747010217 BK010012 0

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