Cleared Special

GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE

K082486 · Bayer Healthcare, LLC · Chemistry
Oct 2008
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K082486 is an FDA 510(k) clearance for the GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE, 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 October 8, 2008, 41 days after receiving the submission on August 28, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K082486 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2008
Decision Date October 08, 2008
Days to Decision 41 days
Submission Type Special
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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