Cleared Traditional

USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100

K930985 · U.S. Drug Testing, Inc. · Toxicology
Apr 1993
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K930985 is an FDA 510(k) clearance for the USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by U.S. Drug Testing, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on April 27, 1993, 61 days after receiving the submission on February 25, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K930985 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1993
Decision Date April 27, 1993
Days to Decision 61 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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