Ldh Reagent Set

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

510(k) Number

K812836 ↗

FDA Product Code

CFH

Device Class

Class II

Regulation

21 CFR Part 862.1440

Advisory Committee

Clinical Chemistry

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• Total & Direct Bilirubin Reagent Set

  Class II

  FDA 510(k) K812841 Active Cleared 27 Nov 1981

• Inorganic Phosphorus Reagent Set

  Class I

  FDA 510(k) K813400 Active Cleared 22 Dec 1981

• Cholesterol Standard

  Class II

  FDA 510(k) K810092 Active Cleared 2 Feb 1981

• Uric Acid Reagent Set

  Class I

  FDA 510(k) K811764 Active Cleared 20 Aug 1981

• Hemoglobin Reagent

  Class II

  FDA 510(k) K821658 Active Cleared 25 Jun 1982

• Creatinine Reagent Set

  Class II

  FDA 510(k) K812834 Active Cleared 3 Dec 1981

See all devices from Anco Medical Reagents & Assoc. →