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

Blood Establishment Computer Software And Accessories

Community Blood Centers Of South Florida

The following data is part of a premarket notification filed by Community Blood Centers Of South Florida 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 IDBK110048
510k NumberBK110048
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 Community Blood Centers Of South Florida 1700 North State Road 7 Lauderhill,  FL  33313
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-07
Decision Date2012-01-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860664000309 BK110048 0
00860003545409 BK110048 0

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.