Cleared Traditional

USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200

K932318 · U.S. Drug Testing, Inc. · Toxicology
Jun 1993
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K932318 is an FDA 510(k) clearance for the USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by U.S. Drug Testing, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on June 15, 1993, 35 days after receiving the submission on May 11, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K932318 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1993
Decision Date June 15, 1993
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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