FDA.reportPublic FDA data

510(k) K060765

Device
HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712
Applicant
HEMOCUE AB
510(k) number
K060765
Product code
LFR  
Decision
Substantially Equivalent (SESE)
Decision date
2006-09-06
Date received
2006-03-21
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
ALLEN WHITE
Address
40 Empire Dr. Lake Forest CA US 92630 92630

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