Cleared Traditional

COLORIMETRIC URIC ACID REAGENT SET

K871417 · Biochemical Trade, Inc. · Chemistry
Apr 1987
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K871417 is an FDA 510(k) clearance for the COLORIMETRIC URIC ACID REAGENT SET, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on April 22, 1987, 15 days after receiving the submission on April 7, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K871417 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1987
Decision Date April 22, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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