Aperio AT2 DX System— 510(k) K190332

Substantially Equivalent

Leica Biosystems Imaging, Inc.

FDA 510(k) clearance K190332 for Aperio AT2 DX System, Substantially Equivalent on 2019-05-20. Applicant: Leica Biosystems Imaging, Inc..

Clearance details

Applicant: Leica Biosystems Imaging, Inc.
Product code: Code PSY
Advisory panel: Pathology
Date received: 2019-02-14
Decision date: 2019-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

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