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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, multipurpose for in vitro coagulation studies
510(k) Number K050016
Device Name HEMOCHRON SIGNATURE ELITE
Applicant
INTERNATIONAL TECHNIDYNE CORP.
8 OLSEN AVE.
EDISON,  NJ  08820
Applicant Contact LESLIE YOUNG
Correspondent
INTERNATIONAL TECHNIDYNE CORP.
8 OLSEN AVE.
EDISON,  NJ  08820
Correspondent Contact LESLIE YOUNG
Regulation Number864.5425
Classification Product Code
JPA  
Date Received01/04/2005
Decision Date 02/10/2005
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
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