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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 K030818
Device Name HEMOCHRON RESPONSE/SYSTEM
Applicant
INTERNATIONAL TECHNIDYNE CORP.
8 OLSEN AVE.
EDISON,  NJ  08820
Applicant Contact JOHN CLAY
Correspondent
INTERNATIONAL TECHNIDYNE CORP.
8 OLSEN AVE.
EDISON,  NJ  08820
Correspondent Contact JOHN CLAY
Regulation Number864.5425
Classification Product Code
JPA  
Date Received03/14/2003
Decision Date 04/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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