← Product Code [CJE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE) · K902560

# ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT (K902560)

_Roche Diagnostic Systems, Inc. · CJE · Jul 17, 1990 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K902560

## Device Facts

- **Applicant:** Roche Diagnostic Systems, Inc.
- **Product Code:** [CJE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE.md)
- **Decision Date:** Jul 17, 1990
- **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/K902560](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJE/K902560)

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