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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K233790
Device Name ACL TOP 970 CL
Applicant
Instrumentation Laboratory
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact Nikita Malladi
Correspondent
Instrumentation Laboratory
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact Nikita Malladi
Regulation Number864.5425
Classification Product Code
JPA  
Subsequent Product Code
GKP  
Date Received11/28/2023
Decision Date 12/29/2023
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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