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FDA 510(k)

i-Stat Alinity System with i-Stat Glucose test

K-Number: K163271 · 2017-04-10

ApplicantAbbott Point of Care, Inc.
Decision Date2017-04-10
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

i-Stat Alinity System with i-Stat Glucose test is a medical device manufactured by Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2017-04-10 under approval number K163271. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i-Stat Alinity System with i-Stat Glucose test?

i-Stat Alinity System with i-Stat Glucose test is a medical device that received FDA 510(k) clearance on 2017-04-10. It is manufactured by Abbott Point of Care, Inc.. The 510(k) number is K163271.

When was i-Stat Alinity System with i-Stat Glucose test approved by the FDA?

i-Stat Alinity System with i-Stat Glucose test received FDA 510(k) clearance on 2017-04-10, under approval number K163271.

What company makes i-Stat Alinity System with i-Stat Glucose test?

i-Stat Alinity System with i-Stat Glucose test is manufactured by Abbott Point of Care, Inc..

What is the FDA product code for i-Stat Alinity System with i-Stat Glucose test?

The FDA product code for i-Stat Alinity System with i-Stat Glucose test is CGA.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Abbott Point of Care, Inc.

K153357i-STAT Alinity System with i-STAT Sodium test K200492i-STAT CG4+ Cartridge with the i-STAT 1 System K183680i-STAT CHEM8+ cartridge with the i-STAT 1 System K191360i-STAT CHEM8+ cartridge with the i-STAT 1 System K183678i-STAT CHEM8+ cartridge with the i-STAT 1 System K183688i-STAT CHEM8+ cartridge with the i-STAT 1 System

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Related Devices (Code: CGA)

K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO K161818GEM Premier 3000Instrumentation Laboratory CO K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry AnalyzerInfrared Laboratory Systems, LLC (Dba Synermed) K163433VITROS Chemistry Products GLU SlidesOrtho Clinical Diagnostics K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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