← Product Code [DCF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF) · K953927

# LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM (K953927)

_International Enzymes, Inc. · DCF · Sep 15, 1995 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K953927

## Device Facts

- **Applicant:** International Enzymes, Inc.
- **Product Code:** [DCF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF.md)
- **Decision Date:** Sep 15, 1995
- **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.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K953927](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K953927)

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