Cleared Traditional

REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE

K974699 · Consolidated Technologies, Inc. · Toxicology
Jan 1998
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K974699 is an FDA 510(k) clearance for the REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on January 22, 1998, 37 days after receiving the submission on December 16, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K974699 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1997
Decision Date January 22, 1998
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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