FDA product code LFP: Conductivity Rate, Urea Nitrogen
LFP is the FDA product code for conductivity rate, urea nitrogen. It is a Class II device, regulated under 21 CFR 862.1770 and reviewed by the Clinical Chemistry panel. FDA has cleared 6 510(k) submissions under LFP, from 6 different applicants. The average 510(k) review took 120 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Conductivity Rate, Urea Nitrogen |
| Device class | Class II |
| Regulation | 21 CFR 862.1770 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LFP clearance
Top LFP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gambro Healthcare | 1 | 2000-01-27 |
| Elan Holdings, Inc. | 1 | 1999-10-14 |
| Sigma Diagnostics, Inc. | 1 | 1996-10-24 |
| Sigma Chemical Co. | 1 | 1993-12-17 |
| A-Kem, Inc. | 1 | 1987-10-23 |
1 more applicants have LFP clearances. See the full list in Caduvo.
Most recent LFP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990039 | Gambro Healthcare | GAMBRO DQM 200 | 2000-01-27 | 386 |
| K992847 | Elan Holdings, Inc. | HICHEM BUN REAGENT | 1999-10-14 | 51 |
| K963537 | Sigma Diagnostics, Inc. | SIGMA DIAGNOSTICS BUN REAGENT | 1996-10-24 | 50 |
| K933679 | Sigma Chemical Co. | SIGMA BUN REAGENT | 1993-12-17 | 142 |
| K873132 | A-Kem, Inc. | BUN REAGENT KIT | 1987-10-23 | 74 |
Recalls for LFP devices
openFDA lists no recalls for product code LFP.
Frequently asked questions
What is FDA product code LFP?
LFP is the FDA product code for conductivity rate, urea nitrogen. It is a Class II device, regulated under 21 CFR 862.1770 and reviewed by the Clinical Chemistry panel.
What device class is LFP?
Class II, regulation 21 CFR 862.1770. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFP?
Across 6 cleared submissions the average was 120 days from receipt to decision (median 62).
Which companies have the most LFP clearances?
Gambro Healthcare (1); Elan Holdings, Inc. (1); Sigma Diagnostics, Inc. (1); Sigma Chemical Co. (1); A-Kem, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LFP
- Run a recall and safety report across every LFP manufacturer
- Watch product code LFP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times