Cleared Traditional

ASCENSIA BREEZE BLOOD GLUCOSE METER

K024062 · Bayer Corp. · Chemistry
Mar 2003
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K024062 is an FDA 510(k) clearance for the ASCENSIA BREEZE BLOOD GLUCOSE METER, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Bayer Corp. (Elkhart, US). The FDA issued a Cleared decision on March 3, 2003, 84 days after receiving the submission on December 9, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K024062 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2002
Decision Date March 03, 2003
Days to Decision 84 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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