Cleared Traditional

K981123 - UREA
(FDA 510(k) Clearance)

K981123 · Trace Scientific , Ltd. · Chemistry

Apr 1998

Decision

28d

Days

Class 2

Risk

K981123 is an FDA 510(k) clearance for the UREA. This device is classified as a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ).

Submitted by Trace Scientific , Ltd. (Victoria, AU). The FDA issued a Cleared decision on April 24, 1998, 28 days after receiving the submission on March 27, 1998.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number	K981123 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 1998
Decision Date	April 24, 1998
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF