Cleared Traditional

EUROCHIMA UREA NITROGEN

K810261 · Volu Sol Medical Industries · Chemistry
Feb 1981
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K810261 is an FDA 510(k) clearance for the EUROCHIMA UREA NITROGEN, a Berthelot Indophenol, Urea Nitrogen (Class II — Special Controls, product code CDL), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on February 10, 1981, 11 days after receiving the submission on January 30, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K810261 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1981
Decision Date February 10, 1981
Days to Decision 11 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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