510(k) K222332
- Device
- MeMed BV
- Applicant
- MeMed Diagnostics, Ltd.
- 510(k) number
- K222332
- Product code
- QPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-23
- Date received
- 2022-08-02
- 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 Heth 5 Tirat Carmel IL 3508504 3508504
FDA Registration Numbers#
- 3005269352
- 3011096386
- 3006165521
- 2182595