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FDA 510(k) Applications Submitted by Dionne Labatore
FDA 510(k) Number
Submission Date
Device Name
Applicant
K232522
08/18/2023
ARK Levetiracetam II Assay
ARK Diagnostics, Inc.
K021787
05/30/2002
VISUCAM
CARL ZEISS OPHTHALMIC SYSTEMS, INC.
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