Cleared Traditional

SPEC(TM) EXTRACTION CARTRIDGE

K901694 · Toxi-Lab, Inc. · Toxicology
Jun 1990
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K901694 is an FDA 510(k) clearance for the SPEC(TM) EXTRACTION CARTRIDGE, a Reagents, Test, Tetrahydrocannabinol (Class II — Special Controls, product code DKE), submitted by Toxi-Lab, Inc. (Irvine, US). The FDA issued a Cleared decision on June 1, 1990, 52 days after receiving the submission on April 10, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K901694 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1990
Decision Date June 01, 1990
Days to Decision 52 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DKE — Reagents, Test, Tetrahydrocannabinol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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