Cleared Special

K992685 - QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C
(FDA 510(k) Clearance)

Oct 1999
Decision
57d
Days
Risk

K992685 is an FDA 510(k) clearance for the QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C. This device is classified as a Kit, Test, Multiple, Drugs Of Abuse, Over The Counter.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on October 6, 1999, 57 days after receiving the submission on August 10, 1999.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number K992685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1999
Decision Date October 06, 1999
Days to Decision 57 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code MVO — Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device Class

Similar Devices — MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

All 17
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
K040327 · Accu-Stat Diagnostics, Inc. · Apr 2004
AT HOME DRUG CUP, MODEL 9150X
K030447 · Phamatech · Apr 2003
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
K014192 · Princeton BioMeditech Corp. · May 2002
PEACE OF MIND HOME DRUG TEST
K013778 · Advantage Diagnostics Corp. · Feb 2002
AT HOME DRUG TEST, MODEL 9074
K013409 · Phamatech, Inc. · Dec 2001
AT HOME DRUG TEST, MODEL 9064
K013410 · Phamatech, Inc. · Dec 2001