Cleared Traditional

DOA-PLUS, DRUGS OF ABUSE CONTROLS

K942257 · Medical Diagnostic Technologies, Inc. · Toxicology
Sep 1994
Decision
128d
Days
Class 1
Risk

About This 510(k) Submission

K942257 is an FDA 510(k) clearance for the DOA-PLUS, DRUGS OF ABUSE CONTROLS, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on September 14, 1994, 128 days after receiving the submission on May 9, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K942257 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1994
Decision Date September 14, 1994
Days to Decision 128 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

Similar Devices — DIF Drug Mixture Control Materials

All 201
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. · Feb 2016
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
K132688 · Biochemical Diagnostics, Inc. · Dec 2013
MULTICHEM WBT
K132174 · Techno-Path Manufacturing , Ltd. · Sep 2013
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
K121122 · Biochemical Diagnostic, Inc. · Jul 2012
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
K121143 · Bio-Rad Laboratories · May 2012
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
K120504 · Bio-Rad Laboratories, Inc. · Mar 2012