Agamatrix

FDA Regulatory Profile

Agamatrix appears in FDA public data with 0 recalls, 14 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jun 6, 2024.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K241304WaveSense Jazz Blood Glucose Monitoring SystemJun 6, 2024
K161834One Drop Blood Glucose Monitoring SystemNov 30, 2016
K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemApr 21, 2016
K132821AGAMATRIX HEALTH MANAGERNov 20, 2013
K130535IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATIONApr 17, 2013
K103544IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV DDec 7, 2011
K101597WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4Oct 18, 2010
K083265JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381Feb 3, 2009
K073573WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEMJan 30, 2008
K072413MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEMSep 27, 2007
K071393JAZZ BLOOD GLUCOSE MONITORING SYSTEMJul 20, 2007
K063409LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067Jan 12, 2007
K062434ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528Nov 13, 2006
K052762LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067Jan 23, 2006