Cleared Special

AT HOME DRUG TEST, MODEL 9078 T

K010654 · Phamatech · Toxicology
Apr 2001
Decision
31d
Days
—
Risk

About This 510(k) Submission

K010654 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9078 T, a Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on April 5, 2001, 31 days after receiving the submission on March 5, 2001. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K010654 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2001
Decision Date April 05, 2001
Days to Decision 31 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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