Cleared Traditional

CALCIUM, AZO DYE REAGENT

K040972 · Genchem, Inc. · Chemistry
Dec 2004
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K040972 is an FDA 510(k) clearance for the CALCIUM, AZO DYE REAGENT, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Genchem, Inc. (Brea, US). The FDA issued a Cleared decision on December 27, 2004, 257 days after receiving the submission on April 14, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K040972 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2004
Decision Date December 27, 2004
Days to Decision 257 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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