Cleared Traditional

SIGMA CALCIUM REAGENT

K933678 · Sigma Chemical Co. · Chemistry
Mar 1994
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K933678 is an FDA 510(k) clearance for the SIGMA CALCIUM REAGENT, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on March 11, 1994, 225 days after receiving the submission on July 29, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K933678 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1993
Decision Date March 11, 1994
Days to Decision 225 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CJY — Azo Dye, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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