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510(k) K111874

Device
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
Applicant
ABBOTT LABORATORIES
510(k) number
K111874
Product code
LFR  
Decision
Substantially Equivalent (SESE)
Decision date
2012-02-16
Date received
2011-07-01
Regulation
862.1345
Classification name
Glucose Dehydrogenase, Glucose
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ARUL STERLIN
Address
1360 S. Loop Rd. Alameda CA US 94502 94502

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LFR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories2015-09-17
K142089ACCU-CHEK AVIVA EXPERT SYSTEMRoche Diagnostics Corporation2014-12-17
K133537EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEMEps Bio Technology Corp.2014-04-28
K131727CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEMCeragem Medisys, Inc.2014-02-28
K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.2013-10-11
K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical Corporation2013-04-04
K121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.2013-02-14
K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical Corporation2012-12-20
K113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.2012-11-09
K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation2012-09-19
K113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMHmd Biomedical, Inc.2012-07-27
K121190CONTOUR NEXT BLOOD GLUCOSE METERBayer Healthcare, LLC2012-07-26
K120042TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation2012-05-22
K121207EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEMEps Bio Technology Corp.2012-05-18
K113768U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation2012-04-12

Legacy Summary#

summary

FDA Review#

Decision Summary