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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name test, donor, syphilis, antigens, treponemal
510(k) Number BK060009
Tradename Galileo Automated Blood Bank System with Capture-S Syphilis Screening Assay
Device Name Test, Syphilis, Treponema (FOR DONOR TESTING)
Original Applicant
Immucor, Inc.
3130 gateway drive
p.o. box 5625
norcross,  GA  30091 5625
Regulation Number866.3830
Classification Product Code
MYR  
Date Received02/01/2006
Decision Date 04/11/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Immunology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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