Agamatrix

FDA Filings

This page includes the latest FDA filings for Agamatrix. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Agamatrix holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3004637226
FEI Number3004637226
NameAGAMATRIX
Owner & OperatorAGAMATRIX
Contact Address7C Raymond Ave --
Salem NH 03079 US
Official Correspondent
  • David Olsen
  • x-603-3286000-6049
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address7C Raymond Ave
SALEM, NH 03079 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
AGAMATRIX
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.42010-10-18
AGAMATRIX
WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM2008-01-30
AGAMATRIX
MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM2007-09-27
AGAMATRIX
JAZZ BLOOD GLUCOSE MONITORING SYSTEM2007-07-20
AGAMATRIX
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-00672007-01-12
AGAMATRIX
ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-015282006-11-13

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