LFP
6 FDA 510(k) clearances · Product code
74 daysmedian time to decision
386 days90th percentile
6clearances measured
FDA profile
- Official device name
- Conductivity Rate, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GAMBRO DQM 200 (K990039) | Gambro Healthcare | 2000-01-27 |
| HICHEM BUN REAGENT (K992847) | Elan Holdings, Inc. | 1999-10-14 |
| SIGMA DIAGNOSTICS BUN REAGENT (K963537) | Sigma Diagnostics, Inc. | 1996-10-24 |
| SIGMA BUN REAGENT (K933679) | Sigma Chemical Co. | 1993-12-17 |
| BUN REAGENT KIT (K873132) | A-Kem, Inc. | 1987-10-23 |
| LIQUILYME BUN REAGENT (K812945) | Amresco, Inc. | 1981-11-06 |
Track LFP automatically
Every clearance here is in the API, with alerts when new ones post.