← Product Code [CJE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE) · K841918

# SIGMA PROCED. 245 ALKALINE PHOSPHATASE (K841918)

_Sigma Diagnostics, Inc. · CJE · Jun 14, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K841918

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [CJE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE.md)
- **Decision Date:** Jun 14, 1984
- **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/K841918](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K841918)

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