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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, quality control for blood banking reagents
510(k) Number BK900010
Tradename Dade Chemically Modified Control Reagent
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Baxter Healthcare Corporation
1851 delaware parkway
miami,  FL  33152
Regulation Number864.9650
Classification Product Code
KSF  
Date Received02/27/1990
Decision Date 09/21/1990
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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