Cleared Traditional

SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K020794 · Bayer Diagnostics Corp. · Toxicology
Jul 2002
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K020794 is an FDA 510(k) clearance for the SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, a Colorimetry, Salicylate (Class II — Special Controls, product code DKJ), submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 11, 2002, 122 days after receiving the submission on March 11, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3830.

Submission Details

510(k) Number K020794 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2002
Decision Date July 11, 2002
Days to Decision 122 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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