Cleared Traditional

URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K022096 · Bayer Diagnostics Corp. · Chemistry
Mar 2003
Decision
264d
Days
Class 1
Risk

About This 510(k) Submission

K022096 is an FDA 510(k) clearance for the URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on March 18, 2003, 264 days after receiving the submission on June 27, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K022096 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2002
Decision Date March 18, 2003
Days to Decision 264 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KNK — Acid, Uric, Uricase (colorimetric)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1775

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