K241304
- 510(k) number
- K241304
- Device name
- WaveSense Jazz Blood Glucose Monitoring System
- Applicant
- Agamatrix NH · US
- Product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Decision date
- 2024-06-06
- Date received
- 2024-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K241304.pdf
Official FDA record: K241304
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.