FDA.reportPublic FDA data

Greg Dickson

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96158373002608770Greg Dickson1N2026-01-01201 Great Valley Parkway Malvern PA US 19355
30001255613000125561Greg Dickson1N2026-01-01201 Great Valley Parkway Malvern PA US 19355
30028951693002895169Greg Dickson1N2026-01-01201 Great Valley Parkway Malvern PA US 19355
80316113004083851Greg Dickson1N2020-04-25201 Great Valley Parkway Malvern PA US 19355

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1720241262246476P160016VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)OBF2017-03-14
706551323341184K971502SERODIA TP-PAGMT1997-11-13
1935901470287116K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET2025-05-16
1720241470287116K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSET2025-05-16
1935901378293477K190702Lumipulse G whole PTHCEW2019-08-30
1935901220056339K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setPRI2017-12-10
1935901919398870K171103Lumipulse G TSH-III Immunoreaction CartridgesJLW2017-07-28
1935901525085836K163544Lumipulse G ProlactinJIT2017-01-12
1935901327355536K163534Lumipulse G FSH-N CalibratorsJIT2017-01-13
1935901050003421K163521Lumipulse G LH CalibratorsJIT2017-01-12
1935901549802962K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsMRG2016-04-15
1935901496795457K153145Lumipulse G TP-N Immunoreaction Cartridge SetLIP2016-07-05
1935901565074980K151378Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsOIU2015-11-24
1935901718059391K142895LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II CalibratorsLTK2015-05-21
706501416518199K101809FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20JJY2010-10-05
706501627044015K100831CYFRA 21-1 EIA MODEL 211-10OVK2011-05-26
706501260018462K072939HE4 EIA, MODEL: 404-10 USOIU2008-06-09
1935901624035742DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)QSE2022-05-04
706551315713011BK960092
706551494908573BK070030
706551699470408BK060062
706551203676419BK030007
1720241015013447
706501429607468
1720241689578601
1720241064490153
1935901135715901
706501138111564
1935901508983017
1720241508983017
1720241552319926

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JIT32017-01-13
SET22025-05-16
PRI22017-12-10
OIU22015-11-24
LTK22015-05-21
QSE12022-05-04
CEW12019-08-30
JLW12017-07-28
OBF12017-03-14
LIP12016-07-05
MRG12016-04-15
OVK12011-05-26
JJY12010-10-05
GMT11997-11-13