Wako CH50 Linearity Set

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K973055 ↗

FDA Product Code

JIW

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Wako Direct Bilirubin V

  Class II

  FDA 510(k) K970986 Active Cleared 7 May 1997

• Wako Autokit CH50

  Class II

  FDA 510(k) K954145 Active Cleared 18 Dec 1995

• Wako Total Bilirubin V

  Class II

  FDA 510(k) K970985 Active Cleared 21 Apr 1997

• Wako Nefa Linearity Set

  Class I

  FDA 510(k) K030065 Active Cleared 11 Feb 2003

• Total Bilirubin Standard Calibrator

  Class II

  FDA 510(k) K872263 Active Cleared 22 Jul 1987

• Wako Autokit Apo A1

  Class I

  FDA 510(k) K952615 Active Cleared 8 Sep 1995

See all devices from Wako Chemicals USA, Inc. →

• What is the WAKO CH50 Linearity Set used for?

  The WAKO CH50 Linearity Set is used to estimate the linearity limits of the reagent/instrument system for the Ch50 analyte in clinical chemistry, specifically with the Wako Autokit Ch50 test.

• How is the WAKO CH50 Linearity Set supplied?

  The device is supplied as a Class 2 device with product code JIW.

• Is the WAKO CH50 Linearity Set cleared by the FDA?

  Yes, the WAKO CH50 Linearity Set has an FDA 510(k) clearance, K973055, and is manufactured by Wako Chemicals USA, Inc.

• What is the medical specialty of the WAKO CH50 Linearity Set?

  The WAKO CH50 Linearity Set is used in Clinical Chemistry.