DMA Glucose Hexokinase U.V. Procedure

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K952437 ↗

FDA Product Code

CFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Hemoglobin Controls

  Class II

  FDA 510(k) K790457 Active Cleared 4 Apr 1979

• Gamma Glutamyl Transferase Procedure

  Class I

  FDA 510(k) K863586 Active Cleared 3 Oct 1986

• Direct Bilirubin Procedure

  Class II

  FDA 510(k) K881166 Active Cleared 28 Apr 1988

• Data-Zyme Glucose Hexokinase UV

  Class II

  FDA 510(k) K801052 Active Cleared 23 May 1980

• Data-Zyme Triglyceride Procedure

  Class I

  FDA 510(k) K780379 Active Cleared 12 May 1978

• Magnesium Procedure

  Class I

  FDA 510(k) K861668 Active Cleared 27 May 1986

See all devices from Data Medical Associates, Inc. →

• What is the DMA Glucose Hexokinase U.V. Procedure used for?

  The DMA Glucose Hexokinase U.V. Procedure is a clinical chemistry device specifically designed for glucose testing in patient samples. It utilizes hexokinase methodology to accurately measure glucose levels.

• What is the regulatory status of this device?

  This device has received FDA 510(k) clearance with number K952437 on October 3, 1995, after a 131-day review period. It is classified as a Class 2 chemistry device with product code CFR.

• How is the DMA Glucose Hexokinase U.V. Procedure supplied?

  The device is supplied as a clinical chemistry test procedure by Data Medical Associates, Inc. It is designed for use in laboratory settings to measure glucose levels in patient samples using hexokinase methodology.

• What is the review process for this device?

  The device underwent a traditional review process by the FDA's Clinical Chemistry advisory committee (CH) and was determined to be substantially equivalent to predicate devices. The review process took 131 days from submission to clearance.