Cleared Traditional

DBEST TETRAHYDROCANNABINOL TEST KIT

K983188 · Ameritek, Inc. · Toxicology
Nov 1998
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K983188 is an FDA 510(k) clearance for the DBEST TETRAHYDROCANNABINOL TEST KIT, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), 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 862.3870.

Submission Details

510(k) Number K983188 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 LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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