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Leica Biosystems Imaging, Inc.

2 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. recall (Z-0046-2020)Leica Biosystems Imaging, Inc.2019-10-04
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast recall (Z-1152-2014)Leica Biosystems Imaging, Inc.2014-03-07

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Every clearance here is in the API, with alerts when new ones post.