SERUM CREATININE - Serum Creatinine
by Fisher Scientific Co., LLC 510(k)
Active
510(k) K800219
Overview
The Serum Creatinine; Alk. Buffer & Picric is a device used for the quantitative determination of creatinine in human serum. It is a type of clinical chemistry device, specifically designed for colorimetry and creatinine testing.
The device is supplied with vials of Creatinine Picric Acid, Creatinine (D) Buffer, and Creatinine (D) Standard. It is regulated under the product code CGX and has a regulation number of 862.1225. The device has been cleared by the FDA under the 510(k) premarket notification process, with a decision description of Substantially Equivalent.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800219 | Date26 Feb 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CGX
- Models / Variants
- Serum Creatinine
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1225
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Fisher Scientific Co., LLC
Questions
What is the Serum Creatinine device used for?
The Serum Creatinine device is used for the quantitative determination of creatinine in human serum, specifically designed for colorimetry and creatinine testing.
How is the device supplied?
The device is supplied with vials of Creatinine Picric Acid, Creatinine (D) Buffer, and Creatinine (D) Standard.
What is the regulatory status of the device?
The device has been cleared by the FDA under the 510(k) premarket notification process, with a decision description of Substantially Equivalent.
What type of device is the Serum Creatinine?
The Serum Creatinine is a type of clinical chemistry device, specifically designed for colorimetry and creatinine testing.