S-Urea-N, In Vitro Diag For Bun
by Advanced Biomedical Methods, Inc. 510(k)
Active
510(k) K761152
Overview
S-Urea-N is an in vitro diagnostic device used for the measurement of blood urea nitrogen (BUN) levels. It operates based on the Berthelot Indophenol method to determine urea nitrogen concentrations in clinical samples.
The device is supplied by Advanced Biomedical Methods, Inc. and is classified under product code CDL with FDA 510(k) clearance K761152. It is intended for use in clinical chemistry laboratories and is regulated as a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK761152 | Date9 Dec 1976 | 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- Withdrawn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 Advanced Biomedical Methods, Inc.
Questions
What is the S-UREA-N device used for?
S-UREA-N is an in vitro diagnostic device designed for measuring blood urea nitrogen (BUN) levels in clinical samples using the Berthelot Indophenol method, primarily for use in clinical chemistry laboratories.
How is the S-UREA-N device supplied?
The S-UREA-N device is supplied by Advanced Biomedical Methods, Inc. and is classified under product code CDL with FDA 510(k) clearance K761152.
What regulatory classification does the S-UREA-N device have?
S-UREA-N is regulated as a Class II medical device with FDA 510(k) clearance K761152, classified under product code CDL, and is intended for clinical chemistry laboratory use.
What method does the S-UREA-N device use for measurement?
The S-UREA-N device operates based on the Berthelot Indophenol method to determine urea nitrogen concentrations in clinical samples.