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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 K243374
Device Name HemosIL CL HIT-IgG(PF4-H)
Applicant
Instrumentation Laboratory (IL) Co.
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact Nikita Malladi
Correspondent
Instrumentation Laboratory (IL) Co.
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact Nikita Malladi
Regulation Number864.7695
Classification Product Code
LCO  
Date Received10/30/2024
Decision Date 01/28/2025
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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