← Product Code [DCF](/productcode/DCF) · K802404

# ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE (K802404)

_Ortho Diagnostics, Inc. · DCF · Oct 23, 1980 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K802404

## Device Facts

- **Applicant:** Ortho Diagnostics, Inc.
- **Product Code:** [DCF](/productcode/DCF.md)
- **Decision Date:** Oct 23, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5040
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

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**Source:** [https://fda-staging.innolitics.com/device/K802404](https://fda-staging.innolitics.com/device/K802404)

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