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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 kit, quality control for blood banking reagents
510(k) Number BK080012
Tradenames (1) Seraclone Control ABO+Rh, (2) Coombscell-E, (3) MLB2
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Biotest Medical Diagnostics GmbH
p.o. box 10 21 50
63267 dreiech, 
Regulation Number864.9650
Classification Product Code
KSF  
Date Received03/17/2008
Decision Date 07/23/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
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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