← Product Code [JGQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ) · K913615

# URINARY/CSF PROTEIN (K913615)

_Boehringer Mannheim Corp. · JGQ · Sep 13, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K913615

## Device Facts

- **Applicant:** Boehringer Mannheim Corp.
- **Product Code:** [JGQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ.md)
- **Decision Date:** Sep 13, 1991
- **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/JGQ/K913615](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K913615)

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