← Product Code [DGB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGB) · K861773

# ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM (K861773)

_Zygotek Systems, Inc. · DGB · Jul 7, 1986 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGB/K861773

## Device Facts

- **Applicant:** Zygotek Systems, Inc.
- **Product Code:** [DGB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGB.md)
- **Decision Date:** Jul 7, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5800
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A seminal fluid (sperm) immunological test system is a device that consists of the reagents used for legal purposes to identify and differentiate animal and human semen. The test results may be used as court evidence in alleged instances of rape and other sex-related crimes.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGB/K861773](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGB/K861773)

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