Cleared Traditional

VITALAB URIC ACID REAGENT

K040467 · Clinical Data, Inc. · Chemistry
Mar 2004
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K040467 is an FDA 510(k) clearance for the VITALAB URIC ACID REAGENT, 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 March 8, 2004, 13 days after receiving the submission on February 24, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K040467 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2004
Decision Date March 08, 2004
Days to Decision 13 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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