Cleared Traditional

URIC ACID

K981766 · Abbott Laboratories · Chemistry
Jun 1998
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K981766 is an FDA 510(k) clearance for the URIC ACID, a Acid, Uric, Uricase (u.v.) (Class I — General Controls, product code CDO), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on June 19, 1998, 31 days after receiving the submission on May 19, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K981766 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1998
Decision Date June 19, 1998
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDO — Acid, Uric, Uricase (u.v.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1775

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