Cleared Traditional

AT HOME DRUG TEST MODELS, 9308T AND 9308X

K070009 · Phamatech, Inc. · Toxicology
Dec 2007
Decision
338d
Days
Class 2
Risk

About This 510(k) Submission

K070009 is an FDA 510(k) clearance for the AT HOME DRUG TEST MODELS, 9308T AND 9308X, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 7, 2007, 338 days after receiving the submission on January 3, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K070009 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2007
Decision Date December 07, 2007
Days to Decision 338 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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