← Product Code [KHT](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KHT) · K822516

# VIVONEX MASS GASTRASTOMY TUBE (K822516)

_Norwich Eaton Pharmaceuticals, Inc. · KHT · Sep 7, 1982 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KHT/K822516

## Device Facts

- **Applicant:** Norwich Eaton Pharmaceuticals, Inc.
- **Product Code:** [KHT](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KHT.md)
- **Decision Date:** Sep 7, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5370
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A Cohn fraction V immunological test system is a device that consists of or measures that fraction of plasma containing predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be depressed, e.g., nephrosis (disease of the kidney), proteinuria (protein in the urine), gastroenteropathy (disease of the stomach and small intestine), rheumatoid arthritis, and viral hepatitis.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KHT/K822516](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KHT/K822516)

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