Dsl Active Aldosterone Ria (Dsl 8600)
by Diagnostic Systems Laboratories, Inc. 510(k)
Active
510(k) K943397
Overview
The Dsl Active Aldosterone Ria (Dsl 8600) is a radioimmunoassay device for aldosterone. It is classified as a device in the clinical chemistry medical specialty. The device is used to measure aldosterone levels.
The device is supplied with a product code of CJM and is regulated under regulation number 862.1045. It has been assigned a k number of K943397 and has an FDA 510K authorization. The device is registered with fei numbers including 3002485711 and has a device class of 2.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK943397 | Date13 Feb 1995 | 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- Withdrawn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
- CJM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1045
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
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