← Product Code [CJE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE) · K890521

# ABBOTT CLINICAL CHEMISTRY REAGENT ALP (K890521)

_Abbott Laboratories · CJE · Mar 24, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K890521

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [CJE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE.md)
- **Decision Date:** Mar 24, 1989
- **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/K890521](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K890521)

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