Cleared Traditional

URIC ACID TEST

K864119 · U. S. Diagnostics, Inc. · Chemistry
Oct 1986
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K864119 is an FDA 510(k) clearance for the URIC ACID TEST, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on October 29, 1986, 8 days after receiving the submission on October 21, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K864119 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1986
Decision Date October 29, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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