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FDA 510(k), K030818, HEMOCHRON RESPONSE/SYSTEM
FDA 510(k), K030818, HEMOCHRON RESPONSE/SYSTEM
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510(K) Number: K030818
Device Name: HEMOCHRON RESPONSE/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: 03/14/2003
Decision Date: 04/02/2003
Regulation Medical Specialty: Hematology
Device Name: HEMOCHRON RESPONSE/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: 03/14/2003
Decision Date: 04/02/2003
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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