DMA Amylase (Demand) Procedure

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K940010 ↗

FDA Product Code

CIJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

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

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• What is the DMA Amylase (Demand) Procedure used for?

  The DMA Amylase (Demand) Procedure is a saccharogenic amylase device used in clinical chemistry to measure amylase enzyme activity, which aids in diagnosing conditions such as pancreatitis or salivary gland disorders by detecting elevated levels in biological fluids.

• How is the DMA Amylase (Demand) Procedure supplied and is it sterile or single-use?

  The device data does not specify supply format, sterility, or single-use/reuse status; therefore, no details about packaging, sterilization method, or intended use duration can be confirmed from the provided information.

• What regulatory pathway was used for the DMA Amylase (Demand) Procedure and when was it cleared?

  The DMA Amylase (Demand) Procedure received FDA 510(k) clearance through a traditional review process on March 11, 1994, under K940010, after being determined substantially equivalent to a legally marketed predicate device.