Colorimetric BUN
by Bio-Analytics Laboratories, Inc. 510(k)
Active
510(k) K831414
Overview
The Colorimetric BUN is a clinical chemistry reagent kit used to determine blood urea nitrogen (BUN) concentration by a colorimetric Berthelot‑Indophenol reaction. The assay provides a quantitative measurement of urea nitrogen in serum or plasma samples for laboratory analysis.
The kit was cleared by the FDA through a traditional 510(k) submission (K831414) and is classified as a Class II device (product code CDL). It is supplied by Bio‑Analytics Laboratories, Inc. in McHenry, Illinois, United States, and is intended for use in clinical laboratory settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831414 | Date16 Jun 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CDL
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1770
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bio-Analytics Laboratories, Inc.
Questions
What is the Colorimetric BUN reagent kit used for?
The Colorimetric BUN is a clinical chemistry reagent kit used to determine blood urea nitrogen (BUN) concentration through a colorimetric Berthelot-Indophenol reaction. It provides quantitative measurement of urea nitrogen in serum or plasma samples for laboratory analysis.
How is the Colorimetric BUN reagent kit supplied?
The kit is supplied by Bio-Analytics Laboratories, Inc. located at 803 N. Front St. Suite 3, McHenry, Illinois 60050, United States. It is intended for use in clinical laboratory settings.
What is the regulatory status of the Colorimetric BUN reagent kit?
The Colorimetric BUN reagent kit was cleared by the FDA through a traditional 510(k) submission (K831414) and is classified as a Class II device with product code CDL. It received FDA clearance on June 16, 1983.
Is the Colorimetric BUN reagent kit single-use or reusable?
The device information does not specify whether the Colorimetric BUN reagent kit is single-use or reusable. For specific usage instructions and limitations, please refer to the product documentation provided by the manufacturer.