Cleared Traditional

CARESIDE URIC ACID

K981604 · Careside, Inc. · Chemistry
Jun 1998
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K981604 is an FDA 510(k) clearance for the CARESIDE URIC ACID, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on June 25, 1998, 58 days after receiving the submission on April 28, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K981604 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1998
Decision Date June 25, 1998
Days to Decision 58 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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