Cleared Traditional

URIC ACID MODEL 3P39

K102568 · Abbott Laboratories · Chemistry
May 2011
Decision
241d
Days
Class 1
Risk

About This 510(k) Submission

K102568 is an FDA 510(k) clearance for the URIC ACID MODEL 3P39, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 6, 2011, 241 days after receiving the submission on September 7, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K102568 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2010
Decision Date May 06, 2011
Days to Decision 241 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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