Cleared Traditional

HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712

K060765 · Hemocue AB · Chemistry
Sep 2006
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K060765 is an FDA 510(k) clearance for the HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Hemocue AB (Lake Forest, US). The FDA issued a Cleared decision on September 6, 2006, 169 days after receiving the submission on March 21, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K060765 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2006
Decision Date September 06, 2006
Days to Decision 169 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
ACCU-CHEK AVIVA EXPERT SYSTEM
K142089 · Roche Diagnostics Corporation · Dec 2014
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