Conductivity Rate, Urea Nitrogen
FDA product code LFP · Class II (moderate risk) · 21 CFR 862.1770 · Clinical Chemistry
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990039 | Gambro DQM 200LFP · Traditional | Gambro Healthcare | 01/27/2000SE |
| K992847 | Hichem Bun ReagentLFP · Traditional | Elan Holdings, Inc. | 10/14/1999SE |
| K963537 | Sigma Diagnostics Bun ReagentLFP · Traditional | Sigma Diagnostics, Inc. | 10/24/1996SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | Sigma Chemical Co. | 12/17/1993SE |
| K873132 | Bun Reagent KitLFP · Traditional | A-Kem, Inc. | 10/23/1987SE |
| K812945 | Liquilyme Bun ReagentLFP · Traditional | Amresco, Inc. | 11/06/1981SE |