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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K200033
Device Name HemosIL von Willebrand Factor Antigen
Applicant
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact Nikita Malladi
Correspondent
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact Nikita Malladi
Regulation Number864.7290
Classification Product Code
GGP  
Date Received01/07/2020
Decision Date 08/19/2020
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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