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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 device, mixing and weighing, semi-automated
510(k) Number BK090010
Tradename Biomixer BM330 with XBee (Wireless) Option
Device Name Device, Mixing and Weighing, Semi-automated
Original Applicant
Ljungberg & Kogel
c/o kamm & associates
333 milford rd.
deerfield,  IL  60015
Regulation Number864.9195
Classification Product Code
MYJ  
Date Received02/27/2009
Decision Date 07/17/2009
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 No
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