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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation, Automated
510(k) Number K231031
Device Name ACL TOP Family 70 Series
Applicant
Instrumentation Laboratory Company
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact Carol Marble
Correspondent
Instrumentation Laboratory Company
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact Carol Marble
Regulation Number864.5400
Classification Product Code
GKP  
Date Received04/11/2023
Decision Date 06/21/2023
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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