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Easymax Self Monitoring Glucose Test System, Model # EPS08005

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082121

by Eps Bio Technology Corp.

Identifiers

510(k) Number
K082121 FDA 510(k)
FDA Product Code
CGA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1345 FDA 510(k)
Regulation Number
862.1345 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Easymax Self Monitoring Glucose Test System, Model # Eps08005, is a device for the quantitative measurement of glucose in fresh capillary whole blood samples. It is designed for self-monitoring of glucose levels in blood samples drawn from the fingertips or forearm.

The Easymax Self Monitoring Glucose Test System, Model # Eps08005, is supplied with a product code of CGA and is classified under regulation number 862.1345. It has been cleared under FDA 510K, with a decision code of SESE, and is intended for use in clinical chemistry applications.

Frequently asked questions

What is the Easymax Self Monitoring Glucose Test System used for?

The Easymax Self Monitoring Glucose Test System is used for the quantitative measurement of glucose in fresh capillary whole blood samples, designed for self-monitoring of glucose levels in blood samples drawn from the fingertips or forearm.

Is the Easymax Glucose Test System supplied with any specific product code?

Yes, the Easymax Self Monitoring Glucose Test System is supplied with a product code of CGA.

What is the regulatory classification of the Easymax Glucose Test System?

The Easymax Self Monitoring Glucose Test System is classified under regulation number 862.1345 and has been cleared under FDA 510K.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Easymax Self Monitoring Glucose Test System, Model # Eps08005, Easymax Self Monitoring Glucose Test System, Model # Eps08005, PDF K082121 - Easymax Self Monitoring Glucose Test System, Model # Eps08005, 510(k) K082121 — EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL ..., www.accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Eps Bio Technology Corp.

Sources (1)

  • FDA 510(k) K082121 24 fields · synced Sep 25, 2026