Wako GOT II - HA

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

Full name

Wako(Tm) Got II - Ha

510(k) Number

K864302 ↗

FDA Product Code

CIT

Device Class

Class II

Regulation

21 CFR Part 862.1100

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 primary function of the Wako GOT II - HA?

  The Wako GOT II - HA is a clinical chemistry device specifically designed for AST/SGOT testing. It functions by facilitating NADH oxidation and NAD reduction processes within clinical chemistry applications.

• What is the regulatory classification of this device?

  The Wako GOT II - HA is classified as a Class II medical device. It has received FDA 510(k) clearance under regulation number 862.1100, which pertains to clinical chemistry test systems.

• Who is the manufacturer of the Wako GOT II - HA?

  This device is manufactured by Wako Chemicals USA, Inc., located in Dallas, Texas. The product is identified by the K-number K864302.