IL TEST(TM) Benzodiazepine
by Instrumentation Laboratory CO
510(k) K914815
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914815 | Date27 Jan 1992 | StatusActive |
Official records
- FDA 510(k) database K914815
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
Overview
AI-generated summary, 23 Sep 2026
The IL TEST(TM) Benzodiazepine is an enzyme immunoassay device for the detection of benzodiazepines. It is intended for use in clinical toxicology.
The device is supplied as a single-use test system. It is not indicated for use in pregnancy or for monitoring therapeutic drug levels.