Cleared Traditional

QUICKSCREEN COCAINE 150 SCREENING TEST

K103295 · Phamatech, Inc. · Toxicology
Feb 2012
Decision
450d
Days
Class 2
Risk

About This 510(k) Submission

K103295 is an FDA 510(k) clearance for the QUICKSCREEN COCAINE 150 SCREENING TEST, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on February 1, 2012, 450 days after receiving the submission on November 8, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K103295 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2010
Decision Date February 01, 2012
Days to Decision 450 days
Submission Type Traditional
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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