Alkaline Phosphatase

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

510(k) Number

K790065 ↗

FDA Product Code

CJE

Device Class

Class II

Regulation

21 CFR Part 862.1050

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K830095 Active Cleared 28 Jan 1983

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  FDA 510(k) K800719 Active Cleared 8 May 1980

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  FDA 510(k) K780013 Active Cleared 30 Jan 1978

See all devices from Macomb Chemical Co. →

• What is the alkaline phosphatase test system used for?

  This test system measures alkaline phosphatase enzyme levels in serum or plasma to help diagnose and monitor abnormalities in the liver, bone, parathyroid gland, or intestine. Elevated or altered levels can indicate metabolic or structural issues in these organs, making it useful for clinical chemistry assessments.

• How is the alkaline phosphatase test system supplied and intended for use?

  The device is supplied as a reagent-based diagnostic kit designed exclusively for single-use in clinical laboratory settings. It is not intended for repeated use or in point-of-care environments outside regulated labs.

• Is the alkaline phosphatase test system sterile?

  The provided specifications do not include any information regarding sterility for this test system. Clinicians should follow manufacturer guidelines and local protocols for handling non-sterile reagents in laboratory settings.

• What regulatory approval does the alkaline phosphatase test system hold?

  The alkaline phosphatase test system holds FDA 510(k) clearance under the product code CJE, classified as a Class II medical device under regulation number 862.1050. This clearance indicates it is deemed substantially equivalent to a predicate device for its intended use.

• Are there different models or sizes available for the alkaline phosphatase test system?

  The specifications reference multiple FEI numbers and registration numbers, which may correspond to variations in reagent kits or lot-specific identifiers. However, no explicit details on distinct models, sizes, or configurations are provided beyond the core product code CJE. Contact Macomb Chemical Co. for specific variations or compatibility.