Data / Medical devices / United States / Agamatrix
Agamatrix: FDA-registered device maker in Derry, NH, United States, 6 510(k) clearances
Agamatrix is registered with the FDA (registration 3004637226) in Derry, NH, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 6, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004637226
- Address
- 34 Route 111 Ste 100, Derry, NH, United States, 03038
- Owner or operator
- AGAMATRIX (9078906)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 16, 2011
- Registered through
- 2026
- Brand names listed
- AgaMatrix, Lancets
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 6, 2024 | K241304 | WaveSense Jazz Blood Glucose Monitoring System | NBW | Substantially Equivalent | Agamatrix | accessdata.fda.gov |
| September 21, 2022 | K221383 | MedtFine Blood Lancet | QRK | Substantially Equivalent | Shanghai Carelife International Trading Co. , Ltd. | accessdata.fda.gov |
| November 30, 2016 | K161834 | One Drop Blood Glucose Monitoring System | NBW | Substantially Equivalent | Agamatrix, Inc. | accessdata.fda.gov |
| April 21, 2016 | K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | NBW | Substantially Equivalent | Agamatrix, Inc. | accessdata.fda.gov |
| January 30, 2008 | K073573 | WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Agamatrix | accessdata.fda.gov |
| September 27, 2007 | K072413 | MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Agamatrix | accessdata.fda.gov |
Compare with other makers
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Glucose Oxidase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated June 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.