Cleared Special

AT HOME DRUG TEST, MODEL 9133

K994236 · Phamatech · Toxicology
Dec 1999
Decision
14d
Days
—
Risk

About This 510(k) Submission

K994236 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9133, a Enzyme Immunoassay, Phencyclidine, submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on December 30, 1999, 14 days after receiving the submission on December 16, 1999. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K994236 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1999
Decision Date December 30, 1999
Days to Decision 14 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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