Cleared Traditional

SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71

K980032 · Diagnostic Chemicals , Ltd. · Toxicology
Mar 1998
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K980032 is an FDA 510(k) clearance for the SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71, a Colorimetry, Salicylate (Class II — Special Controls, product code DKJ), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on March 2, 1998, 56 days after receiving the submission on January 5, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3830.

Submission Details

510(k) Number K980032 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1998
Decision Date March 02, 1998
Days to Decision 56 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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