510(k) K213936
K213936 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON MeMed BV, LIAISON MeMed BV Control Set". The FDA issued a decision of Substantially Equivalent on July 14, 2022. The device falls under product code QPS (Immunoassay For Host Biomarkers Of Infection), a Class II device regulated under 21 CFR 866.3215. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2022
- Date Received
- December 16, 2021
- 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.