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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plasma, coagulation control
510(k) Number K120977
Device Name DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
Original Applicant
INTERNATIONAL TECHNIDYNE CORP.
23 nevsky st.
edison,  NJ  08820
Original Contact lawrence picciano
Regulation Number864.5425
Classification Product Code
GGN  
Date Received04/02/2012
Decision Date 07/03/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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