← Product Code [CJE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE) · K880795

# RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. (K880795)

_Trace America, Inc. · CJE · Apr 18, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K880795

## Device Facts

- **Applicant:** Trace America, Inc.
- **Product Code:** [CJE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE.md)
- **Decision Date:** Apr 18, 1988
- **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/K880795](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K880795)

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