Cleared Traditional

TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)

K910739 · V-Tech, Inc. · Toxicology
Mar 1991
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K910739 is an FDA 510(k) clearance for the TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH), a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by V-Tech, Inc. (El Monte, US). The FDA issued a Cleared decision on March 21, 1991, 28 days after receiving the submission on February 21, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K910739 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1991
Decision Date March 21, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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