Cleared Traditional

TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)

K910738 · V-Tech, Inc. · Toxicology
Mar 1991
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K910738 is an FDA 510(k) clearance for the TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL 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 19, 1991, 26 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 K910738 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1991
Decision Date March 19, 1991
Days to Decision 26 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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