Cleared Special

AT HOME DRUG TEST, MODEL 9063

K994237 · Phamatech · Toxicology
Dec 1999
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K994237 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9063, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), 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. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K994237 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 DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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