Cleared Traditional

UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

K971477 · Trace America, Inc. · Chemistry
May 1997
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K971477 is an FDA 510(k) clearance for the UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST), a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on May 27, 1997, 34 days after receiving the submission on April 23, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K971477 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1997
Decision Date May 27, 1997
Days to Decision 34 days
Submission Type Traditional
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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