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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 K974799
Device Name HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
Applicant
INTERNATIONAL TECHNIDYNE CORP.
23 NEVSKY ST.
EDISON,  NJ  08820
Applicant Contact ROBERT MATLAND
Correspondent
INTERNATIONAL TECHNIDYNE CORP.
23 NEVSKY ST.
EDISON,  NJ  08820
Correspondent Contact ROBERT MATLAND
Regulation Number864.5425
Classification Product Code
JPA  
Date Received12/22/1997
Decision Date 07/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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