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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name manual blood grouping and antibody test systems
510(k) Number BK170066
Tradename IH-Incubator L
Device Name Manual blood grouping and antibody test systems
Original Applicant
Bio-Rad Medical Diagnostics GmbH
industriestrasse 1
dreieich,  63303, 
Regulation Number864.9175
Classification Product Code
PBC  
Date Received06/19/2017
Decision Date 12/18/2017
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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