Cleared Traditional

SIGMA BUN REAGENT

K933679 · Sigma Chemical Co. · Chemistry
Dec 1993
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K933679 is an FDA 510(k) clearance for the SIGMA BUN REAGENT, a Conductivity Rate, Urea Nitrogen (Class II — Special Controls, product code LFP), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on December 17, 1993, 142 days after receiving the submission on July 28, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K933679 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1993
Decision Date December 17, 1993
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LFP — Conductivity Rate, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770