Resubmission of the Kleerzit Reagent

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

510(k) Number

K864866 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

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

• GGTP Reagent/Serum Iron/Salicylate Demand Analyzer

  Class II

  FDA 510(k) K852027 Active Cleared 29 May 1985

See all devices from Advanced Biomedical Methods, Inc. →

• What is the Kleerzit Reagent resubmission used for?

  The Kleerzit Reagent resubmission is a reagent used in clinical chemistry for diagnostic testing, intended to support chemical analysis of biological specimens in laboratory settings.

• How is the Kleerzit Reagent supplied and is it single-use or reusable?

  The reagent is supplied as a single-use in vitro diagnostic product, meaning it is intended for one-time use only and should not be reused after initial application.

• What are the storage and handling requirements for the Kleerzit Reagent?

  Storage and handling should follow standard laboratory practices for chemical reagents as indicated in the device labeling, with no special conditions specified beyond those typical for similar laboratory chemicals.