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FDA 510(k), K120977, DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
FDA 510(k), K120977, DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
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510(K) Number: K120977
Device Name: DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Device Classification Name: plasma, coagulation control
Regulation Number: 864.5425
Classification Product Code: GGN
Date Received: 04/02/2012
Decision Date: 07/03/2013
Regulation Medical Specialty: Hematology
Device Name: DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Device Classification Name: plasma, coagulation control
Regulation Number: 864.5425
Classification Product Code: GGN
Date Received: 04/02/2012
Decision Date: 07/03/2013
Regulation Medical Specialty: Hematology
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