Chem-Pro 1000 Clinical Chemistry-Analysis Sys
510(k) K855091
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK855091 | Date14 Mar 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CDS
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1770
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Chem-Pro 1000 Clinical Chemistry-Analysis Sys is an ion-specific electrode system designed for clinical chemistry applications. It functions as an analytical device used to measure specific chemical components in clinical samples.
This device is regulated under FDA 510(k) clearance K855091 and is classified as a class 2 medical device. It is identified by product code CDS and operates under regulation number 862.1770.
Other devices from Sen Tech Medical Corp.
Questions
AI-generated answers, 22 Sep 2026
What is the primary function of the Chem-Pro 1000?
The Chem-Pro 1000 is an analytical device that utilizes ion-specific electrode technology to measure specific chemical components within clinical samples.
What is the regulatory status of this device?
The Chem-Pro 1000 is a class 2 medical device that has received FDA 510(k) clearance under the number K855091. It is identified by product code CDS and operates under regulation number 862.1770.
Which medical specialty is this system designed for?
This device is designed for use within the clinical chemistry specialty, as indicated by its classification under the clinical chemistry advisory committee.