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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K041905
Device Name HEMOSIL CALIBRATION PLASMA
Original Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford,  MA  01730
Original Contact carol marble
Regulation Number862.1150
Classification Product Code
JIX  
Date Received07/15/2004
Decision Date 09/28/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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