Cleared Special

AT HOME DRUG CUP, MODEL 9150X

K030447 · Phamatech · Toxicology
Apr 2003
Decision
62d
Days
—
Risk

About This 510(k) Submission

K030447 is an FDA 510(k) clearance for the AT HOME DRUG CUP, MODEL 9150X, a Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on April 14, 2003, 62 days after receiving the submission on February 11, 2003. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K030447 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2003
Decision Date April 14, 2003
Days to Decision 62 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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