Cleared Traditional

SIGMA CO2 ACID REAGENT

K933692 · Sigma Chemical Co. · Chemistry
Dec 1993
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K933692 is an FDA 510(k) clearance for the SIGMA CO2 ACID REAGENT, a Ph Rate Measurement, Carbon-dioxide (Class II — Special Controls, product code JFL), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on December 9, 1993, 133 days after receiving the submission on July 29, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K933692 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1993
Decision Date December 09, 1993
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JFL — Ph Rate Measurement, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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