Alkaline Phosphatase (Alp) Procedure No. 245

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K954840 ↗

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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  Class II

  FDA 510(k) K932980 Active Cleared 18 Oct 1993

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• Ethanol Controls, Urine, Levels 1, II, and III

  Class I

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