FDA.reportPublic FDA data

AGAMATRIX

Matched from indexed company URL: AgaMatrix, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30046372263004637226AGAMATRIX1Y2026-01-0134 Route 111 Ste 100 Derry NH US 03038

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00385540109728CareSens S Fit - CareSens S Fit System Kit1-800-880-3034customerservice@agamatrix.com
00385540109759CareSens S - CareSens S Control Solution1-800-880-3034customerservice@agamatrix.com
00385540132504AgaMatrix Lancing Device - 8300-013251-866-906-4197customerservice@agamatrix.com
00385541062206AgaMatrix Lancing Device - 8300-106221-866-906-4197customerservice@agamatrix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
658711086120608K241304WaveSense Jazz Blood Glucose Monitoring SystemNBW2024-06-06
658711777356865K221383MedtFine Blood LancetQRK2022-09-21
658711154941150K161834One Drop Blood Glucose Monitoring SystemNBW2016-11-30
658711735555595K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemNBW2016-04-21
658711839738142K132821AGAMATRIX HEALTH MANAGERNBW2013-11-20
658711010779073K130535IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATIONNBW2013-04-17
658711241561303K103544IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV DNBW2011-12-07
658711454322646K101597WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4NBW2010-10-18
658711996135487K083265JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381NBW2009-02-03
658711952812810K073573WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEMNBW2008-01-30
658711234564719K072413MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEMNBW2007-09-27
658711109445853K071393JAZZ BLOOD GLUCOSE MONITORING SYSTEMNBW2007-07-20
658711606019963K063409LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067NBW2007-01-12
658711837154432K062434ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528NBW2006-11-13
658711755817928K052762LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067NBW2006-01-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW142024-06-06
QRK12022-09-21

PMN#

GUDID#

46 records. Showing 1-40. Next