Alkaline Phosphatase

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

510(k) Number

K823786 ↗

FDA Product Code

CJE

Device Class

Class II

Regulation

21 CFR Part 862.1050

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Glucolour

  Class II

  FDA 510(k) K781308 Active Cleared 31 Aug 1978

• Urea Nitrogen Test Kit

  Class II

  FDA 510(k) K781306 Active Cleared 31 Aug 1978

• Got Procedure

  Not classified

  FDA 510(k) K781309 Active Cleared 31 Aug 1978

• Enzymatic Cholesterol (Colorimetric

  Class I

  FDA 510(k) K823784 Active Cleared 14 Jan 1983

• Direct Creatinine Procedure

  Class II

  FDA 510(k) K823806 Active Cleared 14 Jan 1983

• Chloride Reagent

  Class II

  FDA 510(k) K781460 Active Cleared 10 Oct 1978

See all devices from Analytical & Research Chemicals, Inc. →

• What is the primary function of this Alkaline Phosphatase device?

  This device is a nitrophenylphosphate, alkaline phosphatase or isoenzyme reagent designed for clinical chemistry applications. It is specifically used to measure the activity levels of alkaline phosphatase within laboratory samples.

• How is this device regulated in the United States?

  This device is classified as a class 2 medical device and is regulated under FDA 510(k) clearance number K823786. It was determined to be substantially equivalent to existing devices through the traditional 510(k) submission process.

• Who is the manufacturer of this clinical chemistry reagent?

  The device is manufactured by Analytical & Research Chemicals, Inc., located in McHenry, Illinois. The company is the applicant responsible for the regulatory filing associated with this product.