Cleared Traditional

DBSET MULTIDRUG SCREEN TEST KIT

K990681 · Ameritek, Inc. · Toxicology
Jul 1999
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K990681 is an FDA 510(k) clearance for the DBSET MULTIDRUG SCREEN TEST KIT, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on July 15, 1999, 135 days after receiving the submission on March 2, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K990681 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1999
Decision Date July 15, 1999
Days to Decision 135 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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