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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 K911995
Device Name PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
Applicant
INTERNATIONAL TECHNIDYNE CORP.
23 NEVSKY ST.
EDISON,  NJ  08820
Applicant Contact LES HEIMANN
Correspondent
INTERNATIONAL TECHNIDYNE CORP.
23 NEVSKY ST.
EDISON,  NJ  08820
Correspondent Contact LES HEIMANN
Regulation Number864.7750
Classification Product Code
GJS  
Date Received04/22/1991
Decision Date 07/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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