← Product Code [DGJ](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGJ) · K890689

# ADX TM OPIATES (K890689)

_Abbott Laboratories · DGJ · Aug 25, 1989 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-f%E2%80%94immunological-test-systems/DGJ/K890689

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [DGJ](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGJ.md)
- **Decision Date:** Aug 25, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5230
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A colostrum immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific proteins in colostrum. Colostrum is a substance excreted by the mammary glands during pregnancy and until production of breast milk begins 1 to 5 days after childbirth.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-f%E2%80%94immunological-test-systems/DGJ/K890689](https://fda.innolitics.com/submissions/TX/subpart-f%E2%80%94immunological-test-systems/DGJ/K890689)

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