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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K160445
Device Name HemosIL Silica Clotting Time
Applicant
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact Heather L Harvey
Correspondent
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact Heather L Harvey
Regulation Number864.7925
Classification Product Code
GFO  
Date Received02/17/2016
Decision Date 03/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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