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FDA 510(k), K983475, HEMOCHRON RESPONSE
FDA 510(k), K983475, HEMOCHRON RESPONSE
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510(K) Number: K983475
Device Name: HEMOCHRON RESPONSE
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Device Classification Name: instrument, coagulation
Regulation Number: 864.5400
Classification Product Code: KQG
Date Received: 10/02/1998
Decision Date: 05/03/1999
Regulation Medical Specialty: Hematology
Device Name: HEMOCHRON RESPONSE
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Device Classification Name: instrument, coagulation
Regulation Number: 864.5400
Classification Product Code: KQG
Date Received: 10/02/1998
Decision Date: 05/03/1999
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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