Cleared Special

AT HOME DRUG TEST, MODEL 9073 T

K010650 · Phamatech · Toxicology
Mar 2001
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K010650 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9073 T, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on March 30, 2001, 25 days after receiving the submission on March 5, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K010650 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2001
Decision Date March 30, 2001
Days to Decision 25 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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