Cleared Traditional

UREA

K850937 · Dilab, Inc. · Chemistry
Jun 1985
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K850937 is an FDA 510(k) clearance for the UREA, a Diacetyl-monoxime, Urea Nitrogen (Class II — Special Controls, product code CDW), submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 10, 1985, 95 days after receiving the submission on March 7, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K850937 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1985
Decision Date June 10, 1985
Days to Decision 95 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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