LFR

Product Code: LFR


Products Classified as LFR

607Glucose Dehydrogenase, GlucoseGlucose Test System.

Total Product Life Cycle (TPLC) Devices

607Glucose Dehydrogenase, GlucoseGlucose Test System.

FDA Consensus Standards

Glucose Dehydrogenase, Glucose [32368]21 CFR §862.1345 🔎
Glucose Dehydrogenase, Glucose [35909]21 CFR §862.1345 🔎
Glucose Dehydrogenase, Glucose [35812]21 CFR §862.1345 🔎

Pre-market Notifications for LFR

K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemABOTT LABORATORIES
K142089ACCU-CHEK AVIVA EXPERT SYSTEMROCHE DIAGNOSTICS CORPORATION
K133537EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEMEPS BIO TECHNOLOGY CORP.
K131727CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEMCERAGEM MEDISYS INC.
K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMROCHE DIAGNOSTICS OPERATIONS INC
K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNOVA BIOMEDICAL CORPORATION
K122435NOVA ONE BLOOD GLUCOSE MONITORNOVA BIOMEDICAL CORPORATION
K121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHMD BIOMEDICAL, INC.
K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaiDoc Technology Corporation
K121207EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEMEPS BIO TECHNOLOGY CORP.
K121190CONTOUR NEXT BLOOD GLUCOSE METERBAYER HEALTHCARE LLC
K120042TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEMTaiDoc Technology Corporation
K113768U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEMTaiDoc Technology Corporation
K113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHMD BIOMEDICAL, INC.
K113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMHMD BIOMEDICAL, INC.

Global Unique Device Identification Database

00389154000686Glucose Dehydrogenase, Glucose
00389154000631Glucose Dehydrogenase, Glucose
00389154000624Glucose Dehydrogenase, Glucose
00389145000600Glucose Dehydrogenase, Glucose
00389154000587Glucose Dehydrogenase, Glucose
00389154000501Glucose Dehydrogenase, Glucose
00389154000389Glucose Dehydrogenase, Glucose
00389154000372Glucose Dehydrogenase, Glucose
00389154000204Glucose Dehydrogenase, Glucose
00389154000198Glucose Dehydrogenase, Glucose
00389154000075Glucose Dehydrogenase, Glucose
10365702726106Glucose Dehydrogenase, Glucose
00365702719101Glucose Dehydrogenase, Glucose
00365702712102Glucose Dehydrogenase, Glucose
00365702710108Glucose Dehydrogenase, Glucose

Maude Adverse Events

ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-26
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-26
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-23
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-23
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-23
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-19
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-18
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-16
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-13
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-13
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-12
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-09
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-05
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-03-03
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-28
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-26
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-24
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-21
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-19
ACCU-CHEK INFORM II NON-EU LA STRIPROCHE DIAGNOSTICS2020-02-19
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-14
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIAGNOSTICS2020-02-13
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-13
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-12
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-12
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-10
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIAGNOSTICS2020-02-10
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-10
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-07
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-06
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-02-03
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIAGNOSTICS2020-01-31
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIAGNOSTICS2020-01-17
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-01-16
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-01-16
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-01-16
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-01-16
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-01-02
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2020-01-02
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2019-12-19
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2019-11-19
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2019-11-19
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIAGNOSTICS2019-11-19
ACCU-CHEK AVIVA PLUSROCHE DIABETES CARE, INC.2019-11-15
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2019-11-14
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2019-11-14
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2019-11-07
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2019-11-07
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIAGNOSTICS2019-11-07
ACCU-CHEK ? INFORM II TEST STRIPSROCHE DIAGNOSTICS2019-10-30
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