Cleared Special

CONTOUR NEXT BLOOD GLUCOSE METER

K121190 · Bayer Healthcare, LLC · Chemistry
Jul 2012
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K121190 is an FDA 510(k) clearance for the CONTOUR NEXT BLOOD GLUCOSE METER, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on July 26, 2012, 98 days after receiving the submission on April 19, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K121190 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2012
Decision Date July 26, 2012
Days to Decision 98 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LFR — Glucose Dehydrogenase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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