Cleared Traditional

ACETAMINOPHEN-SL ASSAY

K042330 · Diagnostic Chemicals , Ltd. · Toxicology
Jan 2005
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K042330 is an FDA 510(k) clearance for the ACETAMINOPHEN-SL ASSAY, a Colorimetry, Acetaminophen (Class II — Special Controls, product code LDP), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, Prince Edward, CA). The FDA issued a Cleared decision on January 7, 2005, 133 days after receiving the submission on August 27, 2004. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3030.

Submission Details

510(k) Number K042330 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2004
Decision Date January 07, 2005
Days to Decision 133 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LDP — Colorimetry, Acetaminophen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3030

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