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FDA 510(k)

Audit MicroControls Linearity DROP LQ Blood Glucose

K-Number: K161874 · 2016-08-10

ApplicantAalto Scientific, Ltd.
Decision Date2016-08-10
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Audit MicroControls Linearity DROP LQ Blood Glucose is a medical device manufactured by Aalto Scientific, Ltd.. It received FDA 510(k) clearance on 2016-08-10 under approval number K161874. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Audit MicroControls Linearity DROP LQ Blood Glucose?

Audit MicroControls Linearity DROP LQ Blood Glucose is a medical device that received FDA 510(k) clearance on 2016-08-10. It is manufactured by Aalto Scientific, Ltd.. The 510(k) number is K161874.

When was Audit MicroControls Linearity DROP LQ Blood Glucose approved by the FDA?

Audit MicroControls Linearity DROP LQ Blood Glucose received FDA 510(k) clearance on 2016-08-10, under approval number K161874.

What company makes Audit MicroControls Linearity DROP LQ Blood Glucose?

Audit MicroControls Linearity DROP LQ Blood Glucose is manufactured by Aalto Scientific, Ltd..

What is the FDA product code for Audit MicroControls Linearity DROP LQ Blood Glucose?

The FDA product code for Audit MicroControls Linearity DROP LQ Blood Glucose is JJX.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING 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 NCT07612085 A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT07284511 A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar RECRUITING

Related PubMed Literature

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) PMID: 40036206 Glucosafe 2-A new tool for nutritional management and insulin-therapy in the intensive care unit: Randomized controlled study (the Glucosafe 2 protocol). PloS one (2025)

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Official Source

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