Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1035](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1035) → CJF — Tetrabromophenolphthalein, Albumin

# CJF · Tetrabromophenolphthalein, Albumin

_Clinical Chemistry · 21 CFR 862.1035 · Class 2_

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

## Overview

- **Product Code:** CJF
- **Device Name:** Tetrabromophenolphthalein, Albumin
- **Regulation:** [21 CFR 862.1035](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1035)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K830535](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJF/K830535.md) | FLOW-PAC ALKALINE PHOSPHATE REAGENT SET | Amresco, Inc. | Mar 24, 1983 | SESE |

## Top Applicants

- Amresco, Inc. — 1 clearance

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

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