Cleared Traditional

UREA NITROGEN TEST

K863889 · U. S. Diagnostics, Inc. · Chemistry
Nov 1986
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K863889 is an FDA 510(k) clearance for the UREA NITROGEN TEST, a Berthelot Indophenol, Urea Nitrogen (Class II — Special Controls, product code CDL), submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on November 24, 1986, 49 days after receiving the submission on October 6, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K863889 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1986
Decision Date November 24, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDL — Berthelot Indophenol, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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