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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platelet Factor 4 Radioimmunoassay
510(k) Number K153137
Device Name HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
Applicant
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact Carol Marble
Correspondent
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact Carol Marble
Regulation Number864.7695
Classification Product Code
LCO  
Date Received10/30/2015
Decision Date 07/08/2016
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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