Cleared Special

DIDGET WORLD REPORTS

K093930 · Bayer Healthcare, LLC · Chemistry
Mar 2010
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K093930 is an FDA 510(k) clearance for the DIDGET WORLD REPORTS, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on March 12, 2010, 80 days after receiving the submission on December 22, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K093930 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2009
Decision Date March 12, 2010
Days to Decision 80 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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