Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FreeStyle Precision Neo H Blood Glucose Monitoring System

K-Number: K153330 · 2016-02-19

ApplicantAbbott Diabetes Care, Inc.
Decision Date2016-02-19
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FreeStyle Precision Neo H Blood Glucose Monitoring System is a medical device manufactured by Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2016-02-19 under approval number K153330. 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 H Blood Glucose Monitoring System?

FreeStyle Precision Neo H Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by Abbott Diabetes Care, Inc.. The 510(k) number is K153330.

When was FreeStyle Precision Neo H Blood Glucose Monitoring System approved by the FDA?

FreeStyle Precision Neo H Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-02-19, under approval number K153330.

What company makes FreeStyle Precision Neo H Blood Glucose Monitoring System?

FreeStyle Precision Neo H Blood Glucose Monitoring System is manufactured by Abbott Diabetes Care, Inc..

What is the FDA product code for FreeStyle Precision Neo H Blood Glucose Monitoring System?

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

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026)

Other Devices by Abbott Diabetes Care, Inc.

K171941FreeStyle Precision Neo Blood Glucose Test Strips 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.

↑