Cleared Traditional

DBEST METHAMPHETAMINES TEST KIT

K983189 · Ameritek, Inc. · Toxicology
Nov 1998
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K983189 is an FDA 510(k) clearance for the DBEST METHAMPHETAMINES TEST KIT, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on November 18, 1998, 68 days after receiving the submission on September 11, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K983189 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1998
Decision Date November 18, 1998
Days to Decision 68 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LAF — Gas Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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