Cleared Special

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30

K002694 · Diagnostic Chemicals , Ltd. · Chemistry
Sep 2000
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K002694 is an FDA 510(k) clearance for the UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on September 15, 2000, 17 days after receiving the submission on August 29, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K002694 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2000
Decision Date September 15, 2000
Days to Decision 17 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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