FDA 510(k)

UniStrip1 Generic Blood Glucose Test Strips

K-Number: K160038 · 2016-07-29

Decision Date2016-07-29

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

UniStrip1 Generic Blood Glucose Test Strips is a medical device manufactured by Ok Biotech Co., Ltd.. It received FDA 510(k) clearance on 2016-07-29 under approval number K160038. 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 UniStrip1 Generic Blood Glucose Test Strips?

UniStrip1 Generic Blood Glucose Test Strips is a medical device that received FDA 510(k) clearance on 2016-07-29. It is manufactured by Ok Biotech Co., Ltd.. The 510(k) number is K160038.

When was UniStrip1 Generic Blood Glucose Test Strips approved by the FDA?

UniStrip1 Generic Blood Glucose Test Strips received FDA 510(k) clearance on 2016-07-29, under approval number K160038.

What company makes UniStrip1 Generic Blood Glucose Test Strips?

UniStrip1 Generic Blood Glucose Test Strips is manufactured by Ok Biotech Co., Ltd..

What is the FDA product code for UniStrip1 Generic Blood Glucose Test Strips?

The FDA product code for UniStrip1 Generic 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 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)

Other Devices by Ok Biotech Co., Ltd.

K152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System K162430UniStrip1 Generic Blood Glucose Test Strips K213061SuperCheck Pro Blood Glucose Monitoring System

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

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