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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K023561
Device Name ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
Applicant
International Technidyne Corp.
6 Olsen Ave.
Edison,  NJ  08820
Applicant Contact JOHN CLAY
Correspondent
International Technidyne Corp.
6 Olsen Ave.
Edison,  NJ  08820
Correspondent Contact JOHN CLAY
Regulation Number864.5620
Classification Product Code
GKR  
Date Received10/23/2002
Decision Date 01/31/2003
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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