Cre Buffer Cre Dye
by Alpkem Corp.
510(k) K851993
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851993 | Date30 May 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CGX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1225
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
Cre Buffer Cre Dye is an alkaline picrate, colorimetry, creatinine device used for clinical chemistry testing. It functions as a reagent system designed for the measurement of creatinine levels in clinical samples.
This device is identified by FDA 510(k) number K851993 and is classified under regulation number 862.1225. It is manufactured by Alpkem Corp. and received a decision of substantially equivalent on May 30, 1985.
Other devices from Alpkem Corp.
Questions
AI-generated answers, 6 Oct 2026
What is the primary use of Cre Buffer Cre Dye?
Cre Buffer Cre Dye is a reagent system used for clinical chemistry testing. It is specifically designed to measure creatinine levels in clinical samples using an alkaline picrate colorimetry method.
What is the regulatory status of this creatinine testing device?
This device is manufactured by Alpkem Corp. and is identified by FDA 510(k) number K851993, which indicates it was found to be substantially equivalent to existing devices on May 30, 1985.
Under which regulation is this device classified?
The device is classified under regulation number 862.1225, which pertains to alkaline picrate, colorimetry, creatinine devices used in clinical chemistry settings.