Lysing & Hemoglobin Reagent

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

510(k) Number

K841800 ↗

FDA Product Code

GGK

Device Class

Class I

Regulation

21 CFR Part 864.8540

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Sodium & Potassium Standard Solut

  Class II

  FDA 510(k) K841419 Active Cleared 11 May 1984

• Volume Test Dye 6

  Class I

  FDA 510(k) K841422 Active Cleared 11 May 1984

• Urine Diluent-for Use with Ion Selective Electrode

  Class I

  FDA 510(k) K860143 Active Cleared 10 Feb 1986

• Hemolyse

  Class I

  FDA 510(k) K863503 Active Cleared 3 Oct 1986

• Potassium Chloride Solution -2 Molar

  Class II

  FDA 510(k) K841417 Active Cleared 16 May 1984

• Lithium Reagent

  Class I

  FDA 510(k) K841847 Active Cleared 17 Aug 1984

See all devices from Reagent Laboratory, Inc. →