FDA 510(k), K150041, CORA (Coagulation Resonance Analysis) System
FDA 510(k), K150041, CORA (Coagulation Resonance Analysis) System
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510(K) Number: K150041
Device Name: CORA (Coagulation Resonance Analysis) System
Manufacturer: Coramed Technologies, LLC
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 01/09/2015
Decision Date: 06/26/2015
Regulation Medical Specialty: Hematology
Device Name: CORA (Coagulation Resonance Analysis) System
Manufacturer: Coramed Technologies, LLC
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 01/09/2015
Decision Date: 06/26/2015
Regulation Medical Specialty: Hematology