GGTP Reagent/Serum Iron/Salicylate Demand Analyzer

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K852027 ↗

FDA Product Code

DKJ

Device Class

Class II

Regulation

21 CFR Part 862.3830

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Gluc Opap, in Vitro Diag. for Glucose

  Class II

  FDA 510(k) K761153 Active Cleared 9 Dec 1976

• Magnesium Reagent for Demand Analyzer

  Class I

  FDA 510(k) K850381 Active Cleared 1 Mar 1985

• Ldh Reagent for Demand Analyzer

  Class II

  FDA 510(k) K850378 Active Cleared 1 Mar 1985

• S-Urea-N, In Vitro Diag For Bun

  Class II

  FDA 510(k) K761152 Active Cleared 9 Dec 1976

• Ise Reagents for Demand Analyzer

  Class II

  FDA 510(k) K844021 Active Cleared 10 Dec 1984

• Resubmission of the Kleerzit Reagent

  Class II

  FDA 510(k) K864866 Active Cleared 16 Mar 1987

See all devices from Advanced Biomedical Methods, Inc. →

• What is the GGTP Reagent/Serum Iron/Salicylate Demand Analyzer used for?

  This device is used to measure salicylate, gamma-glutamyl transferase (GGTP), and serum iron levels in clinical laboratory settings. It supports toxicology testing by providing quantitative results for these analytes via colorimetric methodology, aiding in the assessment of patient metabolic and toxicological status.

• How does the GGTP Reagent/Serum Iron/Salicylate Demand Analyzer work?

  The analyzer operates using colorimetry-based technology, where chemical reactions produce color changes proportional to the concentration of salicylate, GGTP, or serum iron in a sample. These color changes are measured optically to determine analyte levels, enabling accurate quantification in clinical toxicology workflows.

• What type of facility is the GGTP Reagent/Serum Iron/Salicylate Demand Analyzer intended for?

  The device is intended for use in clinical laboratory settings, specifically for toxicology testing. It is designed to support laboratory professionals in performing routine or urgent assays for salicylate, GGTP, and serum iron as part of patient diagnostic evaluation.