Cleared Traditional

UREA NITROGEN REAGENT SET

K860419 · Sterling Diagnostics, Inc. · Chemistry
Feb 1986
Decision
7d
Days
Class 2
Risk

About This 510(k) Submission

K860419 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 Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 11, 1986, 7 days after receiving the submission on February 4, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K860419 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1986
Decision Date February 11, 1986
Days to Decision 7 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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