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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 K033414
Device Name ACL TOP MODEL, TOP
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 Received10/27/2003
Decision Date 01/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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