Cleared Traditional

Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series

K153474 · Biochemical Diagnostics, Inc. · Toxicology

Feb 2016

Decision

83d

Days

Class 1

Risk

About This 510(k) Submission

K153474 is an FDA 510(k) clearance for the Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Biochemical Diagnostics, Inc. (Edgewood, US). The FDA issued a Cleared decision on February 23, 2016, 83 days after receiving the submission on December 2, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number	K153474 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2015
Decision Date	February 23, 2016
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF