Cleared Traditional

REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE

K992151 · Consolidated Technologies, Inc. · Toxicology
Jul 1999
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K992151 is an FDA 510(k) clearance for the REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE, a Drug Specific Control Materials (Class I — General Controls, product code LAS), submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on July 14, 1999, 20 days after receiving the submission on June 24, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K992151 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1999
Decision Date July 14, 1999
Days to Decision 20 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LAS — Drug Specific Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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