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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 K964609
Device Name ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
Applicant
Array Medical, Inc.
245 Rt. 22 W.
Bridgewater,  NJ  08807
Applicant Contact PATRICIA E BONNESS
Correspondent
Array Medical, Inc.
245 Rt. 22 W.
Bridgewater,  NJ  08807
Correspondent Contact PATRICIA E BONNESS
Regulation Number864.7140
Classification Product Code
JBP  
Date Received11/18/1996
Decision Date 03/06/1997
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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