Cleared Traditional

URIC ACID REAGENT SET

K914158 · Tech Intl. Co. · Chemistry
Feb 1992
Decision
157d
Days
Class 1
Risk

About This 510(k) Submission

K914158 is an FDA 510(k) clearance for the URIC ACID REAGENT SET, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on February 21, 1992, 157 days after receiving the submission on September 17, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K914158 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 1991
Decision Date February 21, 1992
Days to Decision 157 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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