Cleared Traditional

RAICHEM CALCIUM (OCPC) LIQUID REAGENT

K041009 · Hemagen Diagnostics, Inc. · Chemistry
Jun 2004
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K041009 is an FDA 510(k) clearance for the RAICHEM CALCIUM (OCPC) LIQUID REAGENT, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on June 25, 2004, 67 days after receiving the submission on April 19, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K041009 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2004
Decision Date June 25, 2004
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIC — Cresolphthalein Complexone, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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