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Company-Registration
1470287116
Device Listing 1470287116
Listing Summary
#
Listing key
1470287116
Premarket submission
K242706
Device
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
Applicant
Fujirebio Diagnostics,Inc.
Product code
SET
Decision date
2025-05-16
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
70646
2521625
2521625
Fujirebio Diagnostics, Inc.
1
Y
2026-01-01
201 Great Valley Parkway Malvern PA US 19355
172024
9615837
3002608770
Greg Dickson
1
N
2026-01-01
201 Great Valley Parkway Malvern PA US 19355
193590
3002895169
3002895169
Greg Dickson
1
N
2026-01-01
201 Great Valley Parkway Malvern PA US 19355