Folate Reagent Kit, Aria-II System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K780557 ↗

FDA Product Code

CGN

Device Class

Class II

Regulation

21 CFR Part 862.1295

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is the Folate Reagent Kit, Aria-II System used for?

  The Folate Reagent Kit, Aria-II System is used for the measurement of folic acid via radioimmunoassay, as stated in the device description. It is classified under Clinical Chemistry for this specific analytical purpose.

• How was the Folate Reagent Kit, Aria-II System cleared for market?

  The device received FDA 510(k) clearance under K780557 on May 18, 1978, following a traditional review process, and was determined to be substantially equivalent to a predicate device.

• Who manufactures the Folate Reagent Kit, Aria-II System and what is its product code?

  The Folate Reagent Kit, Aria-II System is manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic and is assigned product code CGN, as specified in the device data.