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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Whole Blood Clotting Time
510(k) Number K983649
Device Name MAX-ACT
Applicant
Array Medical, Inc.
One Harvard Way, Suite 5
Hillsborough Campus
Somerville,  NJ  08876
Applicant Contact MICHAEL F CORSELLO
Correspondent
Array Medical, Inc.
One Harvard Way, Suite 5
Hillsborough Campus
Somerville,  NJ  08876
Correspondent Contact MICHAEL F CORSELLO
Regulation Number864.7140
Classification Product Code
JBP  
Date Received10/16/1998
Decision Date 12/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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