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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K010599
Device Name PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
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 Number864.7750
Classification Product Code
GJS  
Date Received02/28/2001
Decision Date 07/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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