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FDA 510(k)

On Call Express Voice Blood Glucose Monitoring System

K-Number: K191038 · 2019-06-12

ApplicantACON Laboratories, Inc.
Decision Date2019-06-12
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

On Call Express Voice Blood Glucose Monitoring System is a medical device manufactured by ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2019-06-12 under approval number K191038. 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 On Call Express Voice Blood Glucose Monitoring System?

On Call Express Voice Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-06-12. It is manufactured by ACON Laboratories, Inc.. The 510(k) number is K191038.

When was On Call Express Voice Blood Glucose Monitoring System approved by the FDA?

On Call Express Voice Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-06-12, under approval number K191038.

What company makes On Call Express Voice Blood Glucose Monitoring System?

On Call Express Voice Blood Glucose Monitoring System is manufactured by ACON Laboratories, Inc..

What is the FDA product code for On Call Express Voice Blood Glucose Monitoring System?

The FDA product code for On Call Express Voice Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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Related PubMed Literature

PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

Other Devices by ACON Laboratories, Inc.

K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis K181527On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System K180504Mission Lipid Panel Monitoring System K180196On Call Express Mobile Blood Glucose Monitoring System K192175On Call Express II Blood Glucose Monitoring System

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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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