← Product Code [DET](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DET) · K900107

# LD-1 (K900107)

_Boehringer Mannheim Corp. · DET · Jan 18, 1990 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DET/K900107

## Device Facts

- **Applicant:** Boehringer Mannheim Corp.
- **Product Code:** [DET](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DET.md)
- **Decision Date:** Jan 18, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5560
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A lactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the activity of the lactic dehydrogenase enzyme in serum. Increased levels of lactic dehydrogenase are found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood-forming organs). However, the diagnostic usefulness of this device is limited because of the many conditions known to cause increased lactic dehydrogenase levels.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DET/K900107](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DET/K900107)

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