Identifiers
- 510(k) Number
- K812341 FDA 510(k)
- FDA Product Code
- CDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1770 FDA 510(k)
- Regulation Number
- 862.1770 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Urea Nitrogen (BUN) is a device used in clinical chemistry for the quantitative determination of urea nitrogen in blood or serum. It is based on the urease and glutamic dehydrogenase methodology.
The device is supplied as a reagent system for in vitro diagnostic use. It is classified as a Class II medical device under FDA regulation number 862.1770 and was cleared via the traditional 510(k) pathway (K812341) on September 1, 1981, by Pointe Scientific, Inc.
Frequently asked questions
What is the Urea Nitrogen (BUN) device used for?
The Urea Nitrogen (BUN) device is used for the quantitative determination of urea nitrogen in blood or serum. It employs the urease and glutamic dehydrogenase methodology to measure BUN levels, which helps assess kidney function and metabolic status in clinical chemistry testing.
How is the Urea Nitrogen (BUN) reagent system supplied and for what use?
The device is supplied as a reagent system intended for in vitro diagnostic use. It is designed for laboratory testing of blood or serum samples to quantify urea nitrogen concentration, supporting clinical evaluation of renal and metabolic health.
What regulatory pathway was used to clear the Urea Nitrogen (BUN) device?
The Urea Nitrogen (BUN) device was cleared via the traditional 510(k) pathway under submission K812341, with a decision date of September 1, 1981. It is classified as a Class II medical device under FDA regulation number 862.1770 for clinical chemistry.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Urea | Definition, Formula, Production, Uses, & Facts | Britannica
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K812341 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
- FDA Applicant
- Pointe Scientific, Inc.,
Sources (1)
- FDA 510(k) K812341 24 fields · synced Sep 23, 2026