Glucose Standard Solution Calibrator

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

510(k) Number

K871758 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Wako Chemicals USA, Inc. →

• What is the Glucose Standard Solution Calibrator used for?

  This device is used in clinical chemistry to calibrate glucose measurement systems. It provides a known concentration of glucose to ensure diagnostic testing results are accurate and reliable.

• How is the calibrator supplied and is it sterile?

  The calibrator is supplied as a solution and is intended for single-use applications. It is not sterilized and must be stored according to the manufacturer's instructions.

• What is the regulatory status of this device?

  The Glucose Standard Solution Calibrator is regulated under FDA 510(k) clearance and is classified as a Class II medical device.