Cleared Traditional

ACCU-CHEK AVIVA EXPERT SYSTEM

K142089 · Roche Diagnostics Corporation · Chemistry
Dec 2014
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K142089 is an FDA 510(k) clearance for the ACCU-CHEK AVIVA EXPERT SYSTEM, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Roche Diagnostics Corporation (Indianapolos, US). The FDA issued a Cleared decision on December 17, 2014, 138 days after receiving the submission on August 1, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K142089 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2014
Decision Date December 17, 2014
Days to Decision 138 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LFR — Glucose Dehydrogenase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

Similar Devices — LFR Glucose Dehydrogenase, Glucose

All 72
FreeStyle InsuLinx Blood Glucose Monotioring System
K152328 · Abott Laboratories · Sep 2015
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
K133537 · Eps Bio Technology Corp. · Apr 2014
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
K131727 · Ceragem Medisys, Inc. · Feb 2014
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · Roche Diagnostics Operations, Inc. · Oct 2013
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
K122688 · Nova Biomedical Corporation · Apr 2013
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
K121433 · Hmd Biomedical, Inc. · Feb 2013