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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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