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Agamatrix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K241304WaveSense Jazz Blood Glucose Monitoring SystemJune 6, 2024
K161834One Drop Blood Glucose Monitoring SystemNovember 30, 2016
K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemApril 21, 2016
K132821AGAMATRIX HEALTH MANAGERNovember 20, 2013
K130535IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATIONApril 17, 2013
K103544IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV DDecember 7, 2011
K101597WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4October 18, 2010
K083265JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381February 3, 2009
K073573WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEMJanuary 30, 2008
K072413MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEMSeptember 27, 2007
K071393JAZZ BLOOD GLUCOSE MONITORING SYSTEMJuly 20, 2007
K063409LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067January 12, 2007
K062434ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528November 13, 2006
K052762LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067January 23, 2006