Cleared Traditional

USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000

K931227 · U.S. Drug Testing, Inc. · Toxicology
May 1993
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K931227 is an FDA 510(k) clearance for the USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000, a Chromatography (liquid, Gel), Clinical Use (Class I — General Controls, product code KZR), submitted by U.S. Drug Testing, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on May 6, 1993, 57 days after receiving the submission on March 10, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K931227 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1993
Decision Date May 06, 1993
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code KZR — Chromatography (liquid, Gel), Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260

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