← Product Code [CJE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE) · K952746

# ALKALINE PHOSPHATASE REAGENT SYSTEM (K952746)

_Medical Diagnostic Technologies, Inc. · CJE · Nov 27, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K952746

## Device Facts

- **Applicant:** Medical Diagnostic Technologies, Inc.
- **Product Code:** [CJE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE.md)
- **Decision Date:** Nov 27, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1050
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K952746](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K952746)

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