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510(k) K213936

LIAISON MeMed BV, LIAISON MeMed BV Control Set by DiaSorin, Inc. — Product Code QPS

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.

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Other clearances for product code QPS

  • K230944 — MeMed BV (June 30, 2023)
  • K222332 — MeMed BV (March 23, 2023)
  • K210254 — MeMed BV (September 1, 2021)