510(k) K230944
- Device
- MeMed BV
- Applicant
- MeMed Diagnostics, Ltd.
- 510(k) number
- K230944
- Product code
- QPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-30
- Date received
- 2023-04-04
- Regulation
- 866.3215
- Classification name
- Immunoassay For Host Biomarkers Of Infection
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Efrat Hartog-David
- Address
- Nahum Het 7 Tirat Carmel IL 3508506 3508506
FDA Registration Numbers#
- 2182595
- 3006165521
- 3011096386
- 3005269352