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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 media, potentiating for in vitro diagnostic use
510(k) Number BK130070
Tradename MLB 2 10 x 10 mL
Device Name Media, Potentiating for In Vitro Diagnostic Use
Original Applicant
Bio-Rad Medical Diagnostics GmbH
industriestrasse 1
dreieich,  63303,  GERMANY
Regulation Number864.9600
Classification Product Code
KSG  
Date Received11/06/2013
Decision Date 11/27/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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