Creatinine Reagent Set
by Medical Specialties, Inc. 510(k)
Active
510(k) K841070
Overview
The Creatinine Reagent Set is an enzymatic method device used for the quantitative determination of creatinine in clinical chemistry applications. It functions as a diagnostic reagent system to assist in the analysis of creatinine levels.
This device is supplied by Medical Specialties, Inc. and has received FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 862.1225.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK841070 | Date1 May 1984 | 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- Withdrawn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
- JFY
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1225
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Medical Specialties, Inc.
Questions
What is the primary purpose of the Creatinine Reagent Set?
This device is an enzymatic method system designed for the quantitative determination of creatinine levels. It is intended for use in clinical chemistry applications to assist clinicians in analyzing patient creatinine samples.
What is the regulatory status of this reagent set?
The Creatinine Reagent Set is a class 2 medical device under regulation number 862.1225. It has received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to other legally marketed predicate devices.
Who is the manufacturer of this diagnostic system?
The Creatinine Reagent Set is supplied by Medical Specialties, Inc., located in McHenry, Illinois. The company is the applicant of record for the FDA 510(k) clearance associated with this product.