Cleared Traditional

URIC ACID REAGENT

K970867 · Derma Media Lab., Inc. · Chemistry
Apr 1997
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K970867 is an FDA 510(k) clearance for the URIC ACID REAGENT, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on April 21, 1997, 42 days after receiving the submission on March 10, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K970867 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1997
Decision Date April 21, 1997
Days to Decision 42 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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