JGZ · O-Phthalaldehyde, Urea Nitrogen
Clinical Chemistry · 21 CFR 862.1770 · Class 2
Overview
| Product Code | JGZ |
|---|---|
| Device Name | O-Phthalaldehyde, Urea Nitrogen |
| Regulation | 21 CFR 862.1770 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 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 | ROCHE COBAS READY RENAL PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | Oct 12, 1990 | SESE |
| K896236 | COBAS READY BUN REAGENT | Roche Diagnostic Systems, Inc. | Feb 27, 1990 | SESE |
| K883327 | CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST | Heraeus Kulzer, Inc. | Jan 23, 1989 | SESE |
| K863901 | IQ UREA NITROGEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 24, 1986 | SESE |
| K842772 | PHARMACIA B2-MICRO RIA | Pharmacia, Inc. | Nov 1, 1984 | SESE |
| K840213 | BLOOD UREA NITROGEN REAGENT SYS | Sclavo, Inc. | Mar 19, 1984 | SESE |
| K820418 | K.D. COLORIMETRIC BLOOD UREA N2 TEST | King Diagnostics, Inc. | Mar 11, 1982 | SESE |
| K810087 | UREA NITROGEN, KINETIC | Bio-Analytics Laboratories, Inc. | Feb 26, 1981 | SESE |
| K801269 | SERALYZER BLOOD UREA NITROGEN(BUN) | Miles Laboratories, Inc. | Jul 8, 1980 | SESE |
| K792362 | BLOOD UREA NITROGEN REAGENT | Connecticut Diagnostics, Ltd. | Dec 6, 1979 | SESE |
| K770504 | 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
