510(k) K230944
K230944 is an FDA 510(k) premarket notification submitted by MeMed Diagnostics, Ltd. for the device "MeMed BV". The FDA issued a decision of Substantially Equivalent on June 30, 2023. The device falls under product code QPS (Immunoassay For Host Biomarkers Of Infection), a Class II device regulated under 21 CFR 866.3215. MeMed Diagnostics, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2023
- Date Received
- April 4, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay For Host Biomarkers Of Infection
- Device Class
- Class II
- Regulation Number
- 866.3215
- Review Panel
- MI
- Submission Type
A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.