Cleared Traditional

URIC ACID REAGENT SET

K811764 · Anco Medical Reagents & Assoc. · Chemistry
Aug 1981
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K811764 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 Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1981, 59 days after receiving the submission on June 22, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K811764 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1981
Decision Date August 20, 1981
Days to Decision 59 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