Cleared Traditional

URIC ACID REAGENT SET

K844075 · Livonia Diagnostics, Inc. · Chemistry

Oct 1984

Decision

11d

Days

Class 1

Risk

About This 510(k) Submission

K844075 is an FDA 510(k) clearance for the URIC ACID REAGENT SET, a Acid, Uric, Acid Reduction Of Ferric Ion (Class I — General Controls, product code LFQ), submitted by Livonia Diagnostics, Inc. (Livonia, US). The FDA issued a Cleared decision on October 30, 1984, 11 days after receiving the submission on October 19, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number	K844075 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 1984
Decision Date	October 30, 1984
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—