Cleared Traditional

GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS

K033055 · Diamond Diagnostics, Inc. · Chemistry
Jan 2004
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K033055 is an FDA 510(k) clearance for the GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on January 30, 2004, 123 days after receiving the submission on September 29, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K033055 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2003
Decision Date January 30, 2004
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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