GDS Enzymatic Salicylate Reagent

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

510(k) Number

K882038 ↗

FDA Product Code

DKJ

Device Class

Class II

Regulation

21 CFR Part 862.3830

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Gds Technology, LLC →

• What is the GDS Enzymatic Salicylate Reagent used for?

  The GDS Enzymatic Salicylate Reagent is used in clinical toxicology for the measurement of salicylate levels in patient specimens, as it is a colorimetry-based reagent designed for this specific diagnostic purpose in laboratory settings.

• How is the GDS Enzymatic Salicylate Reagent supplied and is it sterile?

  The reagent is supplied as an in vitro diagnostic product in a non-sterile condition, intended for single-use in laboratory environments, and requires storage according to the manufacturer's specified conditions to maintain stability and performance.

• What regulatory pathway was used for the GDS Enzymatic Salicylate Reagent?

  The device received FDA 510(k) clearance under submission K882038 on June 24, 1988, and was determined to be substantially equivalent to a predicate device, which is the regulatory route for Class II medical devices like this one.