Glucose Oxidase Reag for Beckman Analyz

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K761154 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

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

• Resubmission of the Kleerzit Reagent

  Class II

  FDA 510(k) K864866 Active Cleared 16 Mar 1987

See all devices from Advanced Biomedical Methods, Inc. →