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 862.1635](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1635) → JGP — Lowry (Colorimetric), Total Protein

# JGP · Lowry (Colorimetric), Total Protein

_Clinical Chemistry · 21 CFR 862.1635 · Class 2_

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

## Overview

- **Product Code:** JGP
- **Device Name:** Lowry (Colorimetric), Total Protein
- **Regulation:** [21 CFR 862.1635](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1635)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K070757](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGP/K070757.md) | MICROPROTEIN REAGENT SET | Pointe Scientific, Inc., | Dec 4, 2007 | SESE |
| [K964960](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGP/K964960.md) | VITROS CHEMISTRY PRODUCTS UPRO SLIDES | Johnson & Johnson Clinical Diagnostics, Inc. | Feb 18, 1997 | SESE |
| [K863112](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGP/K863112.md) | PROTEINMETER | J. D. Assoc. | Dec 10, 1986 | SESE |
| [K821534](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGP/K821534.md) | HEMATOLOGY DATA MANAGEMENT SYS | Biovation, Inc. | Jun 10, 1982 | SESE |
| [K792347](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGP/K792347.md) | MICRO LOWRY PROTEINTEST | Panmed, Inc. | Dec 6, 1979 | SESE |

## Top Applicants

- Biovation, Inc. — 1 clearance
- J. D. Assoc. — 1 clearance
- Johnson & Johnson Clinical Diagnostics, Inc. — 1 clearance
- Panmed, Inc. — 1 clearance
- Pointe Scientific, Inc., — 1 clearance

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

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