Cleared Traditional

RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT

K896845 · Reagents Applications, Inc. · Chemistry
Feb 1990
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K896845 is an FDA 510(k) clearance for the RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT, a Berthelot Indophenol, Urea Nitrogen (Class II — Special Controls, product code CDL), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on February 16, 1990, 72 days after receiving the submission on December 6, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K896845 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1989
Decision Date February 16, 1990
Days to Decision 72 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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