Multistat III Urea Nitrogen Test
by Instrumentation Laboratory CO 510(k)
Active
510(k) K771442
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771442 | Date22 Aug 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- CDN
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1770
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Multistat III Urea Nitrogen Test is a urease, photometric device used for the quantitative determination of urea nitrogen. It functions as a clinical chemistry diagnostic tool to measure urea nitrogen levels in patient samples.
This device is classified as a Class II medical device under regulation number 862.1770 and product code CDN. It received FDA 510(k) clearance on August 22, 1977, under the application submitted by Instrumentation Laboratory CO.
Other devices from Instrumentation Laboratory Company
Questions
AI-generated answers, 26 Sep 2026
What is the primary function of the Multistat III Urea Nitrogen Test?
This device is a clinical chemistry diagnostic tool that utilizes a urease, photometric method to perform a quantitative determination of urea nitrogen levels within patient samples.
What is the regulatory classification of this test?
The Multistat III Urea Nitrogen Test is classified as a Class II medical device under regulation number 862.1770 and product code CDN. It received FDA 510(k) clearance on August 22, 1977.
Who is the manufacturer of the Multistat III Urea Nitrogen Test?
The device is manufactured by Instrumentation Laboratory CO, located in McHenry, Illinois, which submitted the original 510(k) application for the product.