FDA 510(k), K940957, HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
FDA 510(k), K940957, HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
510(K) Number: K940957
Device Name: HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 03/01/1994
Decision Date: 10/18/1994
Regulation Medical Specialty: Hematology
Total pages: 97
Fully redacted pages: 47
Content pages: 50
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