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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name control, plasma, abnormal
510(k) Number K102552
Device Name HEMOSIL LA POSITIVE CONTROL
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD,  MA  01730
Applicant Contact CAROL MARBLE
Correspondent
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD,  MA  01730
Correspondent Contact CAROL MARBLE
Regulation Number864.5425
Classification Product Code
GGC  
Subsequent Product Codes
GGN   GIZ  
Date Received09/07/2010
Decision Date 04/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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