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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 K091980
Device Name ACL TOP 700 LAS
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD,  MA  01730
Applicant Contact CAROL MARBLE
Correspondent
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD,  MA  01730
Correspondent Contact CAROL MARBLE
Regulation Number864.5400
Classification Product Code
GKP  
Date Received07/01/2009
Decision Date 09/22/2009
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
Recalls CDRH Recalls
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