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 862.1770](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1770) → JGZ — O-Phthalaldehyde, Urea Nitrogen

# JGZ · O-Phthalaldehyde, Urea Nitrogen

_Clinical Chemistry · 21 CFR 862.1770 · Class 2_

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

## Overview

- **Product Code:** JGZ
- **Device Name:** O-Phthalaldehyde, Urea Nitrogen
- **Regulation:** [21 CFR 862.1770](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1770)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

## Classification Rationale

Class II.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K904049](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K904049.md) | ROCHE COBAS READY RENAL PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | Oct 12, 1990 | SESE |
| [K896236](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K896236.md) | COBAS READY BUN REAGENT | Roche Diagnostic Systems, Inc. | Feb 27, 1990 | SESE |
| [K883327](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K883327.md) | CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST | Heraeus Kulzer, Inc. | Jan 23, 1989 | SESE |
| [K863901](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K863901.md) | IQ UREA NITROGEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 24, 1986 | SESE |
| [K842772](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K842772.md) | PHARMACIA B2-MICRO RIA | Pharmacia, Inc. | Nov 1, 1984 | SESE |
| [K840213](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K840213.md) | BLOOD UREA NITROGEN REAGENT SYS | Sclavo, Inc. | Mar 19, 1984 | SESE |
| [K820418](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K820418.md) | K.D. COLORIMETRIC BLOOD UREA N2 TEST | King Diagnostics, Inc. | Mar 11, 1982 | SESE |
| [K810087](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K810087.md) | UREA NITROGEN, KINETIC | Bio-Analytics Laboratories, Inc. | Feb 26, 1981 | SESE |
| [K801269](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K801269.md) | SERALYZER BLOOD UREA NITROGEN(BUN) | Miles Laboratories, Inc. | Jul 8, 1980 | SESE |
| [K792362](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K792362.md) | BLOOD UREA NITROGEN REAGENT | Connecticut Diagnostics, Ltd. | Dec 6, 1979 | SESE |
| [K770504](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGZ/K770504.md) | REAGENT SYSTEM | American Monitor Corp. | Jun 27, 1977 | SESE |

## Top Applicants

- Roche Diagnostic Systems, Inc. — 2 clearances
- American Monitor Corp. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Bio-Analytics Laboratories, Inc. — 1 clearance
- Connecticut Diagnostics, Ltd. — 1 clearance

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

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