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FDA 510(k)

FreeStyle Precision Neo Blood Glucose Test Strips

K-Number: K171941 · 2017-09-27

ApplicantAbbott Diabetes Care, Inc.
Decision Date2017-09-27
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FreeStyle Precision Neo Blood Glucose Test Strips is a medical device manufactured by Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2017-09-27 under approval number K171941. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FreeStyle Precision Neo Blood Glucose Test Strips?

FreeStyle Precision Neo Blood Glucose Test Strips is a medical device that received FDA 510(k) clearance on 2017-09-27. It is manufactured by Abbott Diabetes Care, Inc.. The 510(k) number is K171941.

When was FreeStyle Precision Neo Blood Glucose Test Strips approved by the FDA?

FreeStyle Precision Neo Blood Glucose Test Strips received FDA 510(k) clearance on 2017-09-27, under approval number K171941.

What company makes FreeStyle Precision Neo Blood Glucose Test Strips?

FreeStyle Precision Neo Blood Glucose Test Strips is manufactured by Abbott Diabetes Care, Inc..

What is the FDA product code for FreeStyle Precision Neo Blood Glucose Test Strips?

The FDA product code for FreeStyle Precision Neo Blood Glucose Test Strips is NBW. This falls under the OB/GYN category.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED 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 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

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)

Other Devices by Abbott Diabetes Care, Inc.

K153330FreeStyle Precision Neo H Blood Glucose Monitoring System K193371FreeStyle Libre 2 Flash Glucose Monitoring System K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) K211102FreeStyle Libre 2 Flash Glucose Monitoring System K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) K213996FreeStyle Libre 3 Continuous Glucose Monitoring System

View all 14 devices →

Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

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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