Cleared Traditional

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT

K982251 · Sigma Diagnostics, Inc. · Chemistry
Aug 1998
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K982251 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT, a Acid, Uric, Uricase (u.v.) (Class I — General Controls, product code CDO), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 18, 1998, 53 days after receiving the submission on June 26, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K982251 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1998
Decision Date August 18, 1998
Days to Decision 53 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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