Cleared Traditional

SIGMA CX-3 CALIBRATION STANDARD LEVEL 2

K933693 · Sigma Chemical Co. · Chemistry
Oct 1993
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K933693 is an FDA 510(k) clearance for the SIGMA CX-3 CALIBRATION STANDARD LEVEL 2, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on October 13, 1993, 76 days after receiving the submission on July 29, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K933693 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1993
Decision Date October 13, 1993
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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