Cleared Traditional

POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE

K121065 · Polymed Therapeutics, Inc. · Toxicology
May 2013
Decision
413d
Days
Class 2
Risk

About This 510(k) Submission

K121065 is an FDA 510(k) clearance for the POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Polymed Therapeutics, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on May 24, 2013, 413 days after receiving the submission on April 6, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K121065 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2012
Decision Date May 24, 2013
Days to Decision 413 days
Submission Type Traditional
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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