Agamatrix Health Manager
FDA 510(k) K132821 · Agamatrix, Inc.
510(k) numberK132821
Submission
- Device name
- Agamatrix Health Manager
- Applicant
- Agamatrix, Inc.
Salem, NH, US - Received
- September 9, 2013
- Decision date
- November 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
More from Ascensia Diabetes Care
| 510(k) | Device | Decision |
|---|---|---|
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | 06/06/2024SE |
| K161834 | One Drop Blood Glucose Monitoring SystemNBW · Special | 11/30/2016SE |
| K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemNBW · Traditional | 04/21/2016SE |
| K130535 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationNBW · Special | 04/17/2013SE |
| K103544 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DNBW · Traditional | 12/07/2011SE |
| K101597 | Wavesense Diabetes Manager Model Version 1.3.4NBW · Special | 10/18/2010SE |
| K083265 | Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381NBW · Special | 02/03/2009SE |
| K073573 | Wavesense Keynote Codeless Blood Glucose Monitoring SystemNBW · Special | 01/30/2008SE |
| K072413 | Modification to: Jazz Blood Glucose Monitoring SystemNBW · Special | 09/27/2007SE |
| K071393 | Jazz Blood Glucose Monitoring SystemNBW · Special | 07/20/2007SE |
Questions and answers
When was Agamatrix Health Manager cleared by the FDA?
Agamatrix Health Manager (K132821) received a 510(k) decision of Substantially Equivalent on November 20, 2013, 72 days after the submission was received.
What is the product code of K132821?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.