LFR — Glucose Dehydrogenase, Glucose

21 CFR 862.1345

Class 2
Medical Specialty

CH

Review Panel

CH

Submission Type

1

FDA Authorisations (73)

Device Name K-Number
FreeStyle InsuLinx Blood Glucose Monotioring System K152328
ACCU-CHEK AVIVA EXPERT SYSTEM K142089
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM K133537
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM K131727
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM K131366
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR K122688
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS K121433
NOVA ONE BLOOD GLUCOSE MONITOR K122435
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM K113314
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM K121224
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM K113307
CONTOUR NEXT BLOOD GLUCOSE METER K121190
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM K120042
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM K121207
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM K113768
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) K110587
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM K113243
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER K110894
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM K111268
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS K111874
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