Agamatrix
Derry, NH, US
AGAMATRIX appears in FDA device records in Derry, NH. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Agamatrix between 2006 and 2024. The busiest year on record is 2007, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 2 |
| 2016 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241304 | WaveSense Jazz Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K161834 | One Drop Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K132821 | AGAMATRIX HEALTH MANAGER | NBW | Substantially Equivalent | |
| K130535 | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION | NBW | Substantially Equivalent | |
| K103544 | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D | NBW | Substantially Equivalent | |
| K101597 | WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 | NBW | Substantially Equivalent | |
| K083265 | JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 | NBW | Substantially Equivalent | |
| K073573 | WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K072413 | MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K071393 | JAZZ BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K063409 | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 | NBW | Substantially Equivalent | |
| K062434 | ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 | NBW | Substantially Equivalent | |
| K052762 | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004637226 | 3004637226 | AGAMATRIX | 34 Route 111 Ste 100, Derry, NH 03038 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain