← Product Code [CIO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIO) · K855192

# ALKALINE PHOSPHATASE REAGENT SET (K855192)

_Technostics Intl. · CIO · Jan 14, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIO/K855192

## Device Facts

- **Applicant:** Technostics Intl.
- **Product Code:** [CIO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIO.md)
- **Decision Date:** Jan 14, 1986
- **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/K855192](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIO/K855192)

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