Cleared Traditional

COULTER URIC ACID REAGENT

K897161 · Coulter Electronics, Inc. · Chemistry
Mar 1990
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K897161 is an FDA 510(k) clearance for the COULTER URIC ACID REAGENT, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on March 1, 1990, 63 days after receiving the submission on December 28, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K897161 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1989
Decision Date March 01, 1990
Days to Decision 63 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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