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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K113211
Device Name HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD,  MA  01730
Applicant Contact Jacqueline Emery
Correspondent
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD,  MA  01730
Correspondent Contact Jacqueline Emery
Regulation Number864.5425
Classification Product Code
GGN  
Subsequent Product Codes
GGC   GIZ  
Date Received10/31/2011
Decision Date 01/04/2012
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
Predetermined Change
Control Plan Authorized		 No
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