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FDA 510(k), K170960, CoaguChek Vantus System
FDA 510(k), K170960, CoaguChek Vantus System
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510(K) Number: K170960
Device Name: CoaguChek Vantus System
Manufacturer: Roche Diagnostics
Device Classification Name: test, time, prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 03/31/2017
Decision Date: 12/25/2017
Regulation Medical Specialty: Hematology
Device Name: CoaguChek Vantus System
Manufacturer: Roche Diagnostics
Device Classification Name: test, time, prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 03/31/2017
Decision Date: 12/25/2017
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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