Conductivity Rate, Urea Nitrogen
A conductivity rate test for urea nitrogen is a clinical chemistry laboratory device that measures blood urea nitrogen (BUN) levels using conductivity-based principles, providing an indicator of renal function and nitrogen metabolism. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. It carries product code LFP and is regulated under 21 CFR 862.1770 within the Clinical Chemistry specialty. This device is eligible for third-party review.
Basic Information
- Product Code
- LFP
- Device Class
- FDA class 2
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K990039 | GAMBRO DQM 200 | Jan 27, 2000 | Substantially Equivalent | GAMBRO HEALTHCARE |
| K992847 | HICHEM BUN REAGENT | Oct 14, 1999 | Substantially Equivalent | ELAN HOLDINGS, INC. |
| K963537 | SIGMA DIAGNOSTICS BUN REAGENT | Oct 24, 1996 | Substantially Equivalent | SIGMA DIAGNOSTICS, INC. |
| K933679 | SIGMA BUN REAGENT | Dec 17, 1993 | Substantially Equivalent | SIGMA CHEMICAL CO. |
| K873132 | BUN REAGENT KIT | Oct 23, 1987 | Substantially Equivalent | A-KEM, INC. |
| K812945 | LIQUILYME BUN REAGENT | Nov 06, 1981 | Substantially Equivalent | AMRESCO, INC. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.