Emit D.A.U. Benzodiazepine Assay
by Syva Co. 510(k)
Active
510(k) K931536
Overview
The Emit D.A.U. Benzodiazepine Assay is an enzyme immunoassay used for the detection of benzodiazepines. It functions as a clinical toxicology diagnostic tool to identify the presence of these substances.
This device is regulated under FDA 510(k) clearance K931536 and is classified as a Class II medical device. It is intended for use in clinical settings as specified by its regulatory classification.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK931536 | Date11 May 1993 | 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- Withdrawn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
- Full name
- Emit(R) D.A.U. Benzodiazepine Assay
- 510(k) Number
- FDA Product Code
- JXM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3170
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the primary purpose of the Emit D.A.U. Benzodiazepine Assay?
This device is an enzyme immunoassay designed to function as a clinical toxicology diagnostic tool. Its purpose is to identify the presence of benzodiazepines in clinical settings.
How is this device regulated?
The Emit D.A.U. Benzodiazepine Assay is classified as a Class II medical device and has received FDA 510(k) clearance under the number K931536.
What is the regulatory classification for this assay?
This device is regulated under the clinical toxicology advisory committee and is categorized under regulation number 862.3170.