Cleared Traditional

SIGMA WASH CONCENTRATE SOLUTION

K933703 · Sigma Chemical Co. · Chemistry
Dec 1993
Decision
134d
Days
Class 1
Risk

About This 510(k) Submission

K933703 is an FDA 510(k) clearance for the SIGMA WASH CONCENTRATE SOLUTION, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on December 10, 1993, 134 days after receiving the submission on July 29, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K933703 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1993
Decision Date December 10, 1993
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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