← Product Code [CEK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK) · K861663

# TOTAL PROTEIN PROCEDURE (K861663)

_Data Medical Associates, Inc. · CEK · Jun 13, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K861663

## Device Facts

- **Applicant:** Data Medical Associates, Inc.
- **Product Code:** [CEK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK.md)
- **Decision Date:** Jun 13, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1635
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

## 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 § 862.9.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K861663](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K861663)

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