Salicylate Assay

• • Terminated Z-2884-2016 FDA Class II ·initiated 25 Jul 2016

  Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.

510(k) Number

K961131 ↗

FDA Product Code

DKJ

Device Class

Class II

Regulation

21 CFR Part 862.3830

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• T4 Diagnostic Kit

  Class II

  FDA 510(k) K820251 Active Cleared 5 May 1982

• Serum Tox Calibrator

  Class II

  FDA 510(k) K961372 Active Cleared 1 May 1996

• Methadone Enzyme Immunoassay

  Class II

  FDA 510(k) K934667 Active Cleared 26 Jan 1994

• Cannabinoid Urine Controls

  Class I

  FDA 510(k) K932113 Active Cleared 29 Jun 1993

• Amphetamines Eia Assay Modification

  Class II

  FDA 510(k) K934891 Active Cleared 13 Jan 1994

• Thc Urine Calibrators

  Class II

  FDA 510(k) K923386 Active Cleared 14 Sep 1992

See all devices from Diagnostic Reagents, Inc. →