Cleared Traditional

SIGMA CRE REAGENT

K933697 · Sigma Chemical Co. · Chemistry
Oct 1993
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K933697 is an FDA 510(k) clearance for the SIGMA CRE REAGENT, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on October 18, 1993, 81 days after receiving the submission on July 29, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K933697 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1993
Decision Date October 18, 1993
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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