Cleared Traditional

SALICYLATE-SL ASSAY

K042329 · Diagnostic Chemicals , Ltd. · Toxicology
Dec 2004
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K042329 is an FDA 510(k) clearance for the SALICYLATE-SL ASSAY, a Colorimetry, Salicylate (Class II — Special Controls, product code DKJ), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, Prince Edward, CA). The FDA issued a Cleared decision on December 27, 2004, 122 days after receiving the submission on August 27, 2004. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3830.

Submission Details

510(k) Number K042329 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2004
Decision Date December 27, 2004
Days to Decision 122 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DKJ — Colorimetry, Salicylate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3830

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