Idylla MSI Test— 510(k) K211181

Substantially Equivalent

Biocartis NV

FDA 510(k) clearance K211181 for Idylla MSI Test, Substantially Equivalent on 2023-02-27. Applicant: Biocartis NV.

Clearance details

Applicant: Biocartis NV
Product code: Code PZJ
Advisory panel: Immunology
Date received: 2021-04-20
Decision date: 2023-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mechelen, BE

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