Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K013002 ↗

FDA Product Code

DIF

Device Class

Class I

Regulation

21 CFR Part 862.3280

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Biosite Triage Panel For Drugs Of Abuse (50NG/ML)

  Class II

  FDA 510(k) K931598 Active Cleared 12 May 1993

• Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage Troponin-I and Ck-Mb, Triage Troponin-I

  Class II

  FDA 510(k) K973126 Active Cleared 6 Oct 1997

• Modification to Triage B-Type Natriuretic Peptide (Bnp) Test

  Class II

  FDA 510(k) K032235 Active Cleared 28 Jan 2004

• One Step Eddp (Methadone Metabolite) Test Strip

  Class II

  FDA 510(k) K092048 Active Cleared 19 Apr 2010

• Biosite Diagnostics Opiate Screening Test

  Class II

  FDA 510(k) K902924 Active Cleared 14 Sep 1990

• Triage Tox Drug Screen, Catalog #94000

  Class II

  FDA 510(k) K012745 Active Cleared 10 Jan 2002

See all devices from Biosite Incorporated →