Cleared Traditional

UREA NITROGEN REAGENT SET

K844156 · Livonia Diagnostics, Inc. · Chemistry
Nov 1984
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K844156 is an FDA 510(k) clearance for the UREA NITROGEN REAGENT SET, a Diacetyl-monoxime, Urea Nitrogen (Class II — Special Controls, product code CDW), submitted by Livonia Diagnostics, Inc. (Livonia, US). The FDA issued a Cleared decision on November 13, 1984, 20 days after receiving the submission on October 24, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K844156 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1984
Decision Date November 13, 1984
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDW — Diacetyl-monoxime, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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