O-Phthalaldehyde, Urea Nitrogen
FDA product code JGZ · Class II (moderate risk) · 21 CFR 862.1770 · Clinical Chemistry
11510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K904049 | Roche Cobas Ready Renal Profile Reagent StripJGZ · Traditional | Roche Diagnostic Systems, Inc. | 10/12/1990SE |
| K896236 | Cobas Ready Bun ReagentJGZ · Traditional | Roche Diagnostic Systems, Inc. | 02/27/1990SE |
| K883327 | Clinistat Bun (Blood Urea Nitrogen) Reagent TestJGZ · Traditional | Heraeus Kulzer, Inc. | 01/23/1989SE |
| K863901 | Iq Urea NitrogenJGZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/24/1986SE |
| K842772 | Pharmacia B2-MICRO RiaJGZ · Traditional | Pharmacia, Inc. | 11/01/1984SE |
| K840213 | Blood Urea Nitrogen Reagent SysJGZ · Traditional | Sclavo, Inc. | 03/19/1984SE |
| K820418 | K.D. Colorimetric Blood Urea N2 TestJGZ · Traditional | King Diagnostics, Inc. | 03/11/1982SE |
| K810087 | Urea Nitrogen, KineticJGZ · Traditional | Bio-Analytics Laboratories, Inc. | 02/26/1981SE |
| K801269 | Seralyzer Blood Urea Nitrogen(Bun)JGZ · Traditional | Miles Laboratories, Inc. | 07/08/1980SE |
| K792362 | Blood Urea Nitrogen ReagentJGZ · Traditional | Connecticut Diagnostics, Ltd. | 12/06/1979SE |
| K770504 | Reagent SystemJGZ · Traditional | American Monitor Corp. | 06/27/1977SE |