Cleared Traditional

SIGMA ELECTROLYTE REFERENCE REAGENT

K933696 · Sigma Chemical Co. · Chemistry
Jan 1994
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K933696 is an FDA 510(k) clearance for the SIGMA ELECTROLYTE REFERENCE 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 January 3, 1994, 158 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 K933696 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1993
Decision Date January 03, 1994
Days to Decision 158 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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