Clinicard Uv Amylase Chemistry
by Harleco 510(k)
Active
510(k) K771131
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771131 | Date21 Jul 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- JFJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1070
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Clinicard Uv Amylase Chemistry is a catalytic method device used for the quantitative determination of amylase in clinical chemistry applications. It utilizes enzymatic processes to measure amylase activity within a laboratory setting.
This device is supplied by Harleco and has received FDA 510(k) clearance under the regulation number 862.1070. It is categorized under the clinical chemistry advisory committee and is identified by product code JFJ.
Other devices from Harleco
Questions
AI-generated answers, 24 Sep 2026
What is the primary function of the Clinicard UV Amylase Chemistry?
This device is designed for the quantitative determination of amylase within clinical chemistry applications. It utilizes enzymatic processes to measure amylase activity in a laboratory setting.
What is the regulatory status of this device?
The Clinicard UV Amylase Chemistry has received FDA 510(k) clearance under regulation number 862.1070. It is identified by product code JFJ and falls under the clinical chemistry advisory committee.
Who is the manufacturer of this amylase chemistry device?
This device is supplied by Harleco, located in McHenry, Illinois. The product was cleared for use following a traditional 510(k) submission process.