Cleared Traditional

CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)

K110587 · Bayer Healthcare, LLC · Chemistry
Mar 2012
Decision
393d
Days
Class 2
Risk

About This 510(k) Submission

K110587 is an FDA 510(k) clearance for the CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW), 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 March 28, 2012, 393 days after receiving the submission on March 1, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K110587 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2011
Decision Date March 28, 2012
Days to Decision 393 days
Submission Type Traditional
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

Similar Devices — LFR Glucose Dehydrogenase, Glucose

All 72
FreeStyle InsuLinx Blood Glucose Monotioring System
K152328 · Abott Laboratories · Sep 2015
ACCU-CHEK AVIVA EXPERT SYSTEM
K142089 · Roche Diagnostics Corporation · Dec 2014
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
K133537 · Eps Bio Technology Corp. · Apr 2014
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
K131727 · Ceragem Medisys, Inc. · Feb 2014
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · Roche Diagnostics Operations, Inc. · Oct 2013
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
K122688 · Nova Biomedical Corporation · Apr 2013