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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, coagulation
510(k) Number K983475
Device Name HEMOCHRON RESPONSE
Applicant
INTERNATIONAL TECHNIDYNE CORP.
8 OLSEN AVE.
EDISON,  NJ  08820
Applicant Contact JOHN M CLAY
Correspondent
INTERNATIONAL TECHNIDYNE CORP.
8 OLSEN AVE.
EDISON,  NJ  08820
Correspondent Contact JOHN M CLAY
Regulation Number864.5400
Classification Product Code
KQG  
Subsequent Product Code
JPA  
Date Received10/02/1998
Decision Date 05/03/1999
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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