← Product Code [DDE](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDE) · K820900

# EMIT URINE METHADONE ASSAY #3E319 (K820900)

_Syva Co. · DDE · Apr 26, 1982 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DDE/K820900

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [DDE](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDE.md)
- **Decision Date:** Apr 26, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5200
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A carbonic anhydrase B and C immunological test system is a device that consists of the reagents used to measure by immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DDE/K820900](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DDE/K820900)

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