CDL · Berthelot Indophenol, Urea Nitrogen
Clinical Chemistry · 21 CFR 862.1770 · Class 2
Overview
| Product Code | CDL |
|---|---|
| Device Name | Berthelot Indophenol, 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 (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K896845 | RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT | Reagents Applications, Inc. | Feb 16, 1990 | SESE |
| K893128 | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 | Stanbio Laboratory | Jul 25, 1989 | SESE |
| K871651 | COLORIMETRIC BUN REAGENT KIT | Biochemical Trade, Inc. | May 12, 1987 | SESE |
| K864742 | UREA NITROGEN(BUN), COLORIMETRIC METHOD | Tech-Co, Inc. | Jan 13, 1987 | SESE |
| K863889 | UREA NITROGEN TEST | U. S. Diagnostics, Inc. | Nov 24, 1986 | SESE |
| K863076 | UREAFAST | J. D. Assoc. | Sep 9, 1986 | SESE |
| K860154 | BUN (ENZYMATIC BERTHELOT) REAGENT SET | Sterling Diagnostics, Inc. | Feb 6, 1986 | SESE |
| K831414 | COLORIMETRIC BUN | Bio-Analytics Laboratories, Inc. | Jun 16, 1983 | SESE |
| K822237 | UREA NITROGEN REAGENT SET (MOD. BERTHEL | Sterling Biochemical, Inc. | Aug 16, 1982 | SESE |
| K810261 | EUROCHIMA UREA NITROGEN | Volu Sol Medical Industries | Feb 10, 1981 | SESE |
| K801727 | DATA-ZYME UREA NITROGEN, COLORIMETRIC | Data Medical Associates, Inc. | Sep 9, 1980 | SESE |
| K800902 | BUN-COLOR 2, BLOOD UREA NITROGEN TEST | Sclavo, Inc. | Jun 9, 1980 | SESE |
| K792417 | ELVI BLOOD UREA NITROGEN | Volu Sol Medical Industries | Dec 7, 1979 | SESE |
| K781899 | UREA NITROGEN TEST | Wako Intl., Inc. | Dec 20, 1978 | SESE |
| K781306 | UREA NITROGEN TEST KIT | Analytical & Research Chemicals, Inc. | Aug 31, 1978 | SESE |
| K761152 | S-UREA-N, IN VITRO DIAG FOR BUN | Advanced Biomedical Methods, Inc. | Dec 9, 1976 | SESE |
Top Applicants
- Volu Sol Medical Industries — 2 clearances
- Advanced Biomedical Methods, Inc. — 1 clearance
- Analytical & Research Chemicals, Inc. — 1 clearance
- Bio-Analytics Laboratories, Inc. — 1 clearance
- Biochemical Trade, Inc. — 1 clearance
