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— 510(k) K153474

Substantially Equivalent

Biochemical Diagnostics, Inc.

FDA 510(k) clearance K153474 for 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, Substantially Equivalent on 2016-02-23. Applicant: Biochemical Diagnostics, Inc..

Clearance details

Applicant: Biochemical Diagnostics, Inc.
Product code: Code DIF
Advisory panel: Clinical Toxicology
Date received: 2015-12-02
Decision date: 2016-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgewood, NY, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.