Cleared Traditional

PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

K113314 · Hmd Biomedical, Inc. · Chemistry
Nov 2012
Decision
366d
Days
Class 2
Risk

About This 510(k) Submission

K113314 is an FDA 510(k) clearance for the PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Hmd Biomedical, Inc. (Xinpu Township, Hsinchu County, TW). The FDA issued a Cleared decision on November 9, 2012, 366 days after receiving the submission on November 9, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K113314 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2011
Decision Date November 09, 2012
Days to Decision 366 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

More from Hmd Biomedical, Inc.

View all
GlucoLeader Enhance 2 Blood Glucose Monitoring System
K212248 · NBW · Aug 2022
GlucoLeader Enhance Blood Glucose Monitoring System
K182428 · NBW · May 2019
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30
K140150 · NBW · May 2015
FIA Blood Glucose Monitoring System (G2)
K131173 · NBW · Sep 2014
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
K121433 · LFR · Feb 2013