Modif. Of Emit Urine Benzodiazepine

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K833578 ↗

FDA Product Code

JXM

Device Class

Class II

Regulation

21 CFR Part 862.3170

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• C-Reactive Protein Control

  Class II

  FDA 510(k) K821412 Active Cleared 22 Jul 1982

• Ethyl Alcohol Serum Calibrator

  Class II

  FDA 510(k) K810466 Active Cleared 6 Mar 1981

• Micro Trak Xl System

  Class I

  FDA 510(k) K921747 Active Cleared 1 Oct 1992

• Syva Solid Phase Columns System II

  Class I

  FDA 510(k) K861392 Active Cleared 13 Jun 1986

• Modif. of Emit Cad Disopyramide Assay

  Class II

  FDA 510(k) K833623 Active Cleared 8 Dec 1983

• Emit Auto Cortisol Assay

  Class II

  FDA 510(k) K800245 Active Cleared 3 Mar 1980

See all devices from Syva Co. →

• What is the primary purpose of this device?

  This device is an enzyme immunoassay intended for the measurement of benzodiazepine compounds in urine samples. It specifically detects sedative and hypnotic drugs, including diazepam, chlordiazepoxide, oxazepam, chlorzepate, and flurazepam.

• How is this device classified for regulatory purposes?

  The device is classified as a Class 2 medical device under regulation 862.3170. It received FDA 510(k) clearance under the reference number K833578.

• What is the clinical specialty for this immunoassay?

  This device falls under the clinical toxicology specialty, as it is designed to identify the presence of specific drug compounds within a biological specimen.