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 a medical device manufactured by Biocartis NV. It received FDA 510(k) clearance on 2023-02-27 under approval 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. It is manufactured by Biocartis NV. The 510(k) number is K211181.
When was Idylla MSI Test approved by the FDA?
Idylla MSI Test received FDA 510(k) clearance on 2023-02-27, under approval number K211181.
What company makes Idylla MSI Test?
Idylla MSI Test is manufactured by Biocartis NV.
What is the FDA product code for Idylla MSI Test?
The FDA product code for Idylla MSI Test is PZJ.
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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.