Olympus Aspartate Aminotransferase Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K925155 ↗

FDA Product Code

CIT

Device Class

Class II

Regulation

21 CFR Part 862.1100

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Olympus Direct Bilirubin Reagent

  Class II

  FDA 510(k) K924963 Active Cleared 30 Nov 1992

• Olympus Chloride Reagent, Modification

  Class II

  FDA 510(k) K934136 Active Cleared 5 Nov 1993

• Resectoscope Sheath

  Class II

  FDA 510(k) K931994 Active Cleared 17 Feb 1994

• Olympus Measuring Devices

  Class II

  FDA 510(k) K933717 Active Cleared 2 Nov 1993

• Sterile Disposable Cytology Brush

  Not classified

  FDA 510(k) K802187 Active Cleared 10 Sep 1980

• Olympus Infant Resectoscope and Accessories

  Class II

  FDA 510(k) K904940 Active Cleared 13 Jan 1992

See all devices from Olympus Corp. →

• What is the Olympus Aspartate Aminotransferase Reagent used for?

  The Olympus Aspartate Aminotransferase Reagent is used for the measurement of aspartate aminotransferase (AST/SGOT) through the NADH oxidation/NAD reduction method in clinical chemistry applications.

• How is the Olympus Aspartate Aminotransferase Reagent supplied and intended for use?

  The reagent is supplied by Olympus Corp. and is intended for laboratory use in clinical chemistry testing to measure AST/SGOT levels.

• What regulatory pathway was used for the Olympus Aspartate Aminotransferase Reagent?

  The device was cleared by the FDA through the 510(k) pathway, with substantial equivalence demonstrated under K925155 (cleared January 26, 1993) and K922885 (cleared July 28, 1992).