Cleared Traditional

DRUG OF ABUSE ANALYSIS SYSTEM

K903825 · Technicon Instruments Corp. · Toxicology
Sep 1990
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K903825 is an FDA 510(k) clearance for the DRUG OF ABUSE ANALYSIS SYSTEM, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on September 27, 1990, 38 days after receiving the submission on August 20, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K903825 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1990
Decision Date September 27, 1990
Days to Decision 38 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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