FDA.reportPublic FDA data

Leica Biosystems Imaging, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30067913733006791373Leica Biosystems Imaging, Inc.1N2026-01-011360 Park Center Drive Vista CA US 92081

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2185701039899210K253561Aperio iQC DX SoftwareSIX2026-08-07
2185701237591792K253554Aperio GT 450 DX; Aperio GT 180 DXPSY2026-08-07
2185701785353287K252762HALO AP DxQKQ2025-11-25
2185701884352706K232202Aperio GT 450 DXPSY2024-04-16
2185702045257946K190332Aperio AT2 DX SystemPSY2019-05-20
2185701633430479K141109APERIO EPATHOLOGY EIHC IVD SYSTEMNOT2014-07-29
2185701115714395
2185701633463920

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PSY32026-08-07
SIX12026-08-07
QKQ12025-11-25
NOT12014-07-29

PMN#