Cleared Traditional

SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40

K981872 · Diagnostic Chemicals , Ltd. · Toxicology
Jun 1998
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K981872 is an FDA 510(k) clearance for the SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40, 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 June 29, 1998, 32 days after receiving the submission on May 28, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3830.

Submission Details

510(k) Number K981872 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1998
Decision Date June 29, 1998
Days to Decision 32 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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