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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, residual, wbc in leukoreduced blood
510(k) Number BK030037
Tradename LD-2000 Leukocyte Counter
Device Name Test, Residual, WBC in Leukoreduced Blood
Original Applicant
Kowa Company, Ltd.
c/o quintiles consulting
1801 rockville pike, suite 300
rockville,  MD  20852
Regulation Number864.8625
Classification Product Code
MZG  
Date Received06/27/2003
Decision Date 06/14/2004
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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