← Product Code [CIO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIO) · K772257

# ALKALINE PHOSPHATASE TEST SET (K772257)

_Stanbio Laboratory · CIO · Dec 22, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIO/K772257

## Device Facts

- **Applicant:** Stanbio Laboratory
- **Product Code:** [CIO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIO.md)
- **Decision Date:** Dec 22, 1977
- **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/CIO/K772257](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIO/K772257)

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