Cleared Traditional

ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR

K031044 · Clinical Data, Inc. · Toxicology
Jul 2003
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K031044 is an FDA 510(k) clearance for the ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on July 15, 2003, 105 days after receiving the submission on April 1, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K031044 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2003
Decision Date July 15, 2003
Days to Decision 105 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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