Accu-Chek Easy Blood Glucose System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Accu-Chek (R) Easy (Tm) Blood Glucose System

510(k) Number

K904168 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Accu-Chek Easy Blood Glucose System used for?

  The Accu-Chek Easy Blood Glucose System is used for measuring glucose levels in blood. It employs glucose oxidase-based technology to provide quantitative blood glucose measurements, which is essential for monitoring diabetes management in clinical or home settings.

• How was the Accu-Chek Easy Blood Glucose System cleared for market?

  The Accu-Chek Easy Blood Glucose System received FDA 510(k) clearance through a traditional review process. It was determined to be substantially equivalent to a legally marketed predicate device, with clearance granted under K904168 on October 15, 1990, following submission by Boehringer Mannheim Corp.

• What regulatory classification does the Accu-Chek Easy Blood Glucose System have?

  The Accu-Chek Easy Blood Glucose System is classified as a Class II medical device. This classification is based on its product code CGA and regulation number 862.1345, placing it within the Clinical Chemistry specialty for in vitro diagnostic devices.