Cleared Traditional

RAICHEM GLUCOSE UV (LIQUID)

K041052 · Hemagen Diagnostics, Inc. · Chemistry
Jun 2004
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K041052 is an FDA 510(k) clearance for the RAICHEM GLUCOSE UV (LIQUID), a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on June 30, 2004, 72 days after receiving the submission on April 19, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K041052 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2004
Decision Date June 30, 2004
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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