Cleared Traditional

RAICHEM BUN RATE REAGENT (LIQUID)

K041051 · Hemagen Diagnostics, Inc. · Chemistry
Jun 2004
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K041051 is an FDA 510(k) clearance for the RAICHEM BUN RATE REAGENT (LIQUID), a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), 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 862.1770.

Submission Details

510(k) Number K041051 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 CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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