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FDA 510(k), K163271, i-Stat Alinity System with i-Stat Glucose test
FDA 510(k), K163271, i-Stat Alinity System with i-Stat Glucose test
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510(K) Number: K163271
Device Name: i-Stat Alinity System with i-Stat Glucose test
Manufacturer: Abbott Point of Care, Inc.
Device Classification Name: glucose oxidase, glucose
Regulation Number: 862.1345
Classification Product Code: CGA
Date Received: 11/21/2016
Decision Date: 04/10/2017
Regulation Medical Specialty: Clinical Chemistry
Device Name: i-Stat Alinity System with i-Stat Glucose test
Manufacturer: Abbott Point of Care, Inc.
Device Classification Name: glucose oxidase, glucose
Regulation Number: 862.1345
Classification Product Code: CGA
Date Received: 11/21/2016
Decision Date: 04/10/2017
Regulation Medical Specialty: Clinical Chemistry
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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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