Cleared Traditional

DC-ACETA/SAL CONTROLS

K041666 · Diagnostic Chemicals , Ltd. · Toxicology
Aug 2004
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K041666 is an FDA 510(k) clearance for the DC-ACETA/SAL CONTROLS, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, Prince Edward, CA). The FDA issued a Cleared decision on August 17, 2004, 60 days after receiving the submission on June 18, 2004. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K041666 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2004
Decision Date August 17, 2004
Days to Decision 60 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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