Cleared Special

AT HOME DRUG TEST, MODEL 9064

K013410 · Phamatech, Inc. · Toxicology
Dec 2001
Decision
52d
Days
—
Risk

About This 510(k) Submission

K013410 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9064, a Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 6, 2001, 52 days after receiving the submission on October 15, 2001. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K013410 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2001
Decision Date December 06, 2001
Days to Decision 52 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 —

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