← Product Code [JLB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLB) · K782156

# UNITEST CREATINE KINASE (K782156)

_Boehringer Mannheim Corp. · JLB · Mar 2, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLB/K782156

## Device Facts

- **Applicant:** Boehringer Mannheim Corp.
- **Product Code:** [JLB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLB.md)
- **Decision Date:** Mar 2, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1210
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLB/K782156](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLB/K782156)

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