CDS · Electrode, Ion Specific, Urea Nitrogen
Clinical Chemistry · 21 CFR 862.1770 · Class 2
Overview
| Product Code | CDS |
|---|---|
| Device Name | Electrode, Ion Specific, 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | Epocal, Inc. | Jan 17, 2018 | SESE |
| K040973 | BUN REAGENT | Genchem, Inc. | Dec 27, 2004 | SESE |
| K033056 | BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT | Diamond Diagnostics, Inc. | Jan 30, 2004 | SESE |
| K925550 | HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 | Hichem Diagnostics | Apr 20, 1993 | SESE |
| K860543 | BLOOD UREA NITROGEN (BUN) TESTCARD | Ilex Corp. | Apr 21, 1986 | SESE |
| K855091 | CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS | Sen Tech Medical Corp. | Mar 14, 1986 | SESE |
| K812308 | LANCER BUN RATE REAGENT KIT | Sherwood Medical Co. | Aug 31, 1981 | SESE |
| K811193 | BUN RATE REAGENT | Chem-Elec, Inc. | Jul 10, 1981 | SESE |
| K800616 | BUN REAGENT KIT #88108 | Hi Chem, Inc. | Apr 10, 1980 | SESE |
| K800590 | BUN KIT | Nobel Scientific Industries, Inc. | Apr 4, 1980 | SESE |
| K800071 | BUN REAGENT KIT | Fisher Scientific Co., LLC | Feb 5, 1980 | SESE |
| K791018 | FERMCOTEST R BUN RATE REAGENT TEST KIT | Fermco Biochemics, Inc. | Jul 17, 1979 | SESE |
| K771060 | DIAG. CONDUCTA RATE BUN REAG. SET | J.T. Baker Chemical Co. | Jul 21, 1977 | SESE |
| K761061 | BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 | Beckman Instruments, Inc. | Jan 25, 1977 | SESE |
| K760430 | BUN-REATIVE | Boehringer Mannheim Corp. | Nov 1, 1976 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Chem-Elec, Inc. — 1 clearance
- Diamond Diagnostics, Inc. — 1 clearance
- Epocal, Inc. — 1 clearance
