Abuscreen Online Calibrators
by Roche Diagnostic Systems, Inc. 510(k)
Active
510(k) K946000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK946000 | Date25 Jan 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Abuscreen Online(R) Calibrators
- 510(k) Number
- FDA Product Code
- DKJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3830
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Abuscreen Online Calibrators are colorimetric calibrators designed for use with salicylate assays in clinical toxicology. These calibrators provide standardized reference solutions to ensure accurate measurement of salicylate levels in patient samples, supporting reliable diagnostic testing.
Supplied as single-use reagents, these calibrators are intended for in vitro use within clinical laboratory settings. They are regulated under FDA 510(k) clearance (K946000) and classified as Class II devices under product code DKJ. No MRI safety or sterility information is specified, and storage conditions are not detailed in the provided data.