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LFR — Glucose Dehydrogenase, Glucose Class II

FDA Device Classification

FDA product code LFR covers "Glucose Dehydrogenase, Glucose", a Class II medical device regulated under 21 CFR 862.1345. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LFR
Device Class
Class II
Regulation Number
862.1345
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K152328abott laboratoriesFreeStyle InsuLinx Blood Glucose Monotioring SystemSeptember 17, 2015
K142089roche diagnostics corporationACCU-CHEK AVIVA EXPERT SYSTEMDecember 17, 2014
K133537eps bio technologyEGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCApril 28, 2014
K131727ceragem medisysCERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEMFebruary 28, 2014
K131366roche diagnostics operationsACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMOctober 11, 2013
K122688nova biomedical corporationNOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORApril 4, 2013
K121433hmd biomedicalGOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE)February 14, 2013
K122435nova biomedical corporationNOVA ONE BLOOD GLUCOSE MONITORDecember 20, 2012
K113314hmd biomedicalPRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMNovember 9, 2012
K121224taidoc technology corporationGENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMSeptember 19, 2012
K113307hmd biomedicalGL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMJuly 27, 2012
K121190bayer healthcareCONTOUR NEXT BLOOD GLUCOSE METERJuly 26, 2012
K120042taidoc technology corporationTD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SMay 22, 2012
K121207eps bio technologyEASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING May 18, 2012
K113768taidoc technology corporationU-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEMApril 12, 2012
K113243eps bio technologyEM50 SELF MONITORING BLOOD GLUCOSE SYSTEMMarch 28, 2012
K110894bayer healthcareCONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERMarch 28, 2012
K110587bayer healthcareCONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONMarch 28, 2012
K111268bayer healthcareCONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMMarch 6, 2012
K111874abbott laboratoriesFREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMSFebruary 16, 2012

FDA data resources