LFP · Conductivity Rate, Urea Nitrogen
Clinical Chemistry · 21 CFR 862.1770 · Class 2
Overview
| Product Code | LFP |
|---|---|
| Device Name | Conductivity Rate, 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990039 | GAMBRO DQM 200 | Gambro Healthcare | Jan 27, 2000 | SESE |
| K992847 | HICHEM BUN REAGENT | Elan Holdings, Inc. | Oct 14, 1999 | SESE |
| K963537 | SIGMA DIAGNOSTICS BUN REAGENT | Sigma Diagnostics, Inc. | Oct 24, 1996 | SESE |
| K933679 | SIGMA BUN REAGENT | Sigma Chemical Co. | Dec 17, 1993 | SESE |
| K873132 | BUN REAGENT KIT | A-Kem, Inc. | Oct 23, 1987 | SESE |
| K812945 | LIQUILYME BUN REAGENT | Amresco, Inc. | Nov 6, 1981 | SESE |
Top Applicants
- A-Kem, Inc. — 1 clearance
- Amresco, Inc. — 1 clearance
- Elan Holdings, Inc. — 1 clearance
- Gambro Healthcare — 1 clearance
- Sigma Chemical Co. — 1 clearance
