510(k) K241304
- Device
- WaveSense Jazz Blood Glucose Monitoring System
- Applicant
- Agamatrix
- 510(k) number
- K241304
- Product code
- NBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-06
- Date received
- 2024-05-09
- Regulation
- 862.1345
- Classification name
- System, Test, Blood Glucose, Over The Counter
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Dave Valcourt
- Address
- 7c Raymond Ave. Salem NH US 03079 03079
FDA Registration Numbers
- 1450662
- 2030633
- 3012188053
- 3004009431
- 3030979885
- 1066444
- 3021286079
- 3013160357
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Source Documents
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| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | 2023-08-10 |
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| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-12-21 |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2022-11-18 |