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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K014008
Device Name HEMOCHRON JR. CITRATE APTT CUVETTE
Applicant
Itc, Inc.
8 Olsen Ave.
Edison,  NJ  08820
Applicant Contact JOHN CLAY
Correspondent
Itc, Inc.
8 Olsen Ave.
Edison,  NJ  08820
Correspondent Contact JOHN CLAY
Regulation Number864.7925
Classification Product Code
GFO  
Date Received12/05/2001
Decision Date 01/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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