Aperio GT 450 DX
K-Number: K232202 · 2024-04-16
ApplicantLeica Biosystems Imaging, Inc.
Decision Date2024-04-16
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent
Device Summary
Aperio GT 450 DX is a medical device manufactured by Leica Biosystems Imaging, Inc.. It received FDA 510(k) clearance on 2024-04-16 under approval number K232202. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aperio GT 450 DX?
Aperio GT 450 DX is a medical device that received FDA 510(k) clearance on 2024-04-16. It is manufactured by Leica Biosystems Imaging, Inc.. The 510(k) number is K232202.
When was Aperio GT 450 DX approved by the FDA?
Aperio GT 450 DX received FDA 510(k) clearance on 2024-04-16, under approval number K232202.
What company makes Aperio GT 450 DX?
Aperio GT 450 DX is manufactured by Leica Biosystems Imaging, Inc..
What is the FDA product code for Aperio GT 450 DX?
The FDA product code for Aperio GT 450 DX is PSY.
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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.