EZ-RANGE

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

510(k) Number

K941965 ↗

FDA Product Code

JPK

Device Class

Class II

Regulation

21 CFR Part 864.8625

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Tri-Count 16

  Class II

  FDA 510(k) K902389 Active Cleared 22 Aug 1990

• Retic-Quinox

  Class II

  FDA 510(k) K993496 Active Cleared 30 Nov 1999

• Mcc Uricheck Assayed Liquid Urine Multiconstituent Control

  Class I

  FDA 510(k) K012243 Active Cleared 20 Aug 2001

• Quantify(901)

  Class I

  FDA 510(k) K972710 Active Cleared 15 Aug 1997

• Meter Trax

  Class II

  FDA 510(k) K904461 Active Cleared 26 Oct 1990

• Centrifiq Blood Control

  Class II

  FDA 510(k) K935343 Active Cleared 27 Jan 1994

See all devices from Hematronix, Inc. →

• What is the EZ-RANGE device intended for?

  The EZ-RANGE device is intended for use in hematology applications as a hematology quality control mixture device, based on its classification and description in the device data.

• Is the EZ-RANGE device supplied sterile or non-sterile?

  The EZ-RANGE device is supplied as non-sterile, as explicitly stated in the device data under specifications where it indicates the device is not sterile.

• Is the EZ-RANGE device designed for single-use or reuse?

  The EZ-RANGE device is supplied as a single-use device, meaning it is intended for one-time use only and not for reuse, as directly stated in the device data.

• What regulatory pathway was used for the EZ-RANGE device?

  The EZ-RANGE device received authorization through the FDA 510(k) pathway, as indicated in the AUTHORIZATIONS field of the device data, which lists FDA_510K.

• What regulation number governs the EZ-RANGE device?

  The EZ-RANGE device is regulated under 21 CFR 864.8625, as specified in the regulation_number field within the openfda section of the device data.