Cleared Traditional

URIC ACID TEST KIT

K901001 · Elite Technology, Inc. · Chemistry
May 1990
Decision
82d
Days
Class 1
Risk

About This 510(k) Submission

K901001 is an FDA 510(k) clearance for the URIC ACID TEST KIT, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Elite Technology, Inc. (Canada M9w 5p1, CA). The FDA issued a Cleared decision on May 23, 1990, 82 days after receiving the submission on March 2, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K901001 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1990
Decision Date May 23, 1990
Days to Decision 82 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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