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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
Models DCJACT-N, DCJACT-A, DCJLR-N, DCJLR-A
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 (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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