Cleared Traditional

U-DOA CONTROLS

K961724 · Medical Diagnostic Technologies, Inc. · Toxicology
Jun 1996
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K961724 is an FDA 510(k) clearance for the U-DOA CONTROLS, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on June 3, 1996, 31 days after receiving the submission on May 3, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K961724 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1996
Decision Date June 03, 1996
Days to Decision 31 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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