Cleared Special

MODIFICATION TO RAICHEM CALCIUM REAGENT

K022049 · Hemagen Diagnostics, Inc. · Chemistry
Jul 2002
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K022049 is an FDA 510(k) clearance for the MODIFICATION TO RAICHEM CALCIUM REAGENT, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on July 19, 2002, 25 days after receiving the submission on June 24, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K022049 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2002
Decision Date July 19, 2002
Days to Decision 25 days
Submission Type Special
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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