Ultrachem E-Glu #64976 & 65040

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

510(k) Number

K821470 ↗

FDA Product Code

CFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ultrachem Uric Acid Aidh, #65047

  Class I

  FDA 510(k) K821465 Active Cleared 2 Jun 1982

• Phosphorus Test (Phos) Item Number 65416

  Class I

  FDA 510(k) K945322 Active Cleared 7 Dec 1994

• Immunohematological Saline #97139

  Class I

  FDA 510(k) K831200 Active Cleared 9 May 1983

• Midas 1000 Wright Stain #66010

  Class I

  FDA 510(k) K822980 Active Cleared 27 Oct 1982

• Ultrachem E-Glu, #64976 & 65040

  Class II

  FDA 510(k) K821461 Active Cleared 2 Jun 1982

• Unitized Hematology Set 65132/93

  Class I

  FDA 510(k) K840477 Active Cleared 5 Mar 1984

See all devices from Emd Chemicals, Inc. →

• What is the Ultrachem E-Glu glucose test system used for?

  The Ultrachem E-Glu #64976 & 65040 is a glucose test system designed for laboratory use to measure glucose quantitatively in blood and other body fluids. It is classified under clinical chemistry devices.

• What are the model numbers available for the Ultrachem E-Glu system?

  The Ultrachem E-Glu system is available in two model numbers: #64976 and #65040. These different models may indicate variations in size or configuration, though specific differences aren't detailed in the provided information.

• Is the Ultrachem E-Glu system single-use or reusable?

  The device information does not specify whether the Ultrachem E-Glu system is designed for single-use or multiple uses. This detail would need to be confirmed with the manufacturer or through additional product documentation.

• What is the regulatory status of the Ultrachem E-Glu system?

  The Ultrachem E-Glu #64976 & 65040 was cleared through the FDA 510(k) pathway on June 2, 1982. It is classified as a Class 2 device with product code CFR, indicating it meets the FDA's requirements for safety and effectiveness.