TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM

System, Test, Blood Glucose, Over The Counter

NIPRO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Nipro Diagnostics, Inc. with the FDA for True Metrix Self-monitoring Blood Glucose System, True Metrix Pro Professional Monitoring Blood Glucose System.

Pre-market Notification Details

Device IDK140100
510k NumberK140100
Device Name:TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant NIPRO DIAGNOSTICS, INC. 2400 NW 55TH COURT Fort Lauderdale,  FL  33309
ContactBeth Foster
CorrespondentBeth Foster
NIPRO DIAGNOSTICS, INC. 2400 NW 55TH COURT Fort Lauderdale,  FL  33309
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-15
Decision Date2014-08-01

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