Accuclot Control I, Model A4089

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K003328 ↗

FDA Product Code

GIZ

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sigma Diagnostics, Inc. →

• What is the primary purpose of the Accuclot Control I, Model A4089?

  This device is designed to function as a normal plasma control for hematology applications. It is intended for use in laboratory testing environments to support accurate diagnostic procedures.

• How is the Accuclot Control I classified for regulatory purposes?

  The Accuclot Control I, Model A4089 is classified as a Class II medical device under regulation number 864.5425. It is categorized under product code GIZ and has received FDA 510(k) clearance under K003328.

• Who is the manufacturer of this plasma control device?

  The device is manufactured by Sigma Diagnostics, Inc., which is based in St. Louis, Missouri. The company manages the production and regulatory compliance for this specific model.