Cleared Traditional

URIC ACID REAGENT SET

K860111 · Technostics Intl. · Chemistry
Feb 1986
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K860111 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 Technostics Intl. (Washington, US). The FDA issued a Cleared decision on February 19, 1986, 37 days after receiving the submission on January 13, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K860111 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1986
Decision Date February 19, 1986
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LFQ — Acid, Uric, Acid Reduction Of Ferric Ion
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1775