Cleared Traditional

ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM

K062347 · Bayer Healthcare, LLC · Chemistry
Nov 2006
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K062347 is an FDA 510(k) clearance for the ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Bayer Healthcare, LLC (Mishawaka, US). The FDA issued a Cleared decision on November 22, 2006, 104 days after receiving the submission on August 10, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K062347 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2006
Decision Date November 22, 2006
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NBW — System, Test, Blood Glucose, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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