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FDA 510(k)

Idylla MSI Test

K-Number: K211181 · 2023-02-27

ApplicantBiocartis NV
Decision Date2023-02-27
Product CodePZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Idylla MSI Test is the device name listed in this FDA 510(k) record. The listed applicant is Biocartis NV. It received FDA 510(k) clearance on 2023-02-27 under 510(k) number K211181. The device is classified under product code PZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Idylla MSI Test?

Idylla MSI Test is a medical device that received FDA 510(k) clearance on 2023-02-27. The listed applicant is Biocartis NV. The 510(k) number is K211181.

When did Idylla MSI Test receive FDA 510(k) clearance?

Idylla MSI Test received FDA 510(k) clearance on 2023-02-27, under 510(k) number K211181.

Who is the listed applicant for Idylla MSI Test?

The FDA 510(k) record lists Biocartis NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Idylla MSI Test?

The FDA product code for Idylla MSI Test is PZJ.

Related Devices (Code: PZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213348BOND MMR Antibody PanelLeica Biosystems Newcastle, Ltd.K200129OncoMate MSI Dx Analysis SystemPromega Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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