Cleared Traditional

DART UREA NITROGEN

K894836 · Coulter Electronics, Inc. · Chemistry
Oct 1989
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K894836 is an FDA 510(k) clearance for the DART UREA NITROGEN, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on October 30, 1989, 91 days after receiving the submission on July 31, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K894836 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1989
Decision Date October 30, 1989
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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