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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
Recalls CDRH Recalls
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