FDA.reportPublic FDA data

Ian Pilcher

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80230183002807272Ian Pilcher1N2026-01-011000 Lake Hazeltine Dr Chaska MN US 55318
96122963002807663Ian Pilcher1N2026-01-011000 Lake Hazeltine Dr Chaska MN US 55318
96807461000206808Ian Pilcher1N2026-01-011000 Lake Hazeltine Dr Chaska MN US 55318
30027210513002721051Ian Pilcher1N2026-01-011000 Lake Hazeltine Dr Chaska MN US 55318
30032447103003244710Ian Pilcher1N2026-01-011000 Lake Hazeltine Dr Chaska MN US 55318
30066770293006677029Ian Pilcher1N2026-01-011000 Lake Hazeltine Dr Chaska MN US 55318
30077503723007750372Ian Pilcher1N2026-01-011000 Lake Hazeltine Dr Chaska MN US 55318
30082443723008244372Ian Pilcher1N2026-01-011000 Lake Hazeltine Dr Chaska MN US 55318
30169549413016954941Ian Pilcher1N2026-01-011000 Lake Hazeltine Dr Chaska MN US 55318
30279775083027977508Ian Pilcher1N2026-01-011000 Lake Hazeltine Dr Chaska MN US 55318

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
52611767854931P230015Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QCLOM2025-10-17
1071811474528724K993444K-ASSAY ALPHA-1 ATDEM1999-11-24
1071812063696359K992086OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2JIX1999-08-19
1071812072494530K991136B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEMJZG1999-05-11
1368631985342169K981743OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZERCKB1998-06-09
1071811272967575K981305OLYMPUS SERUM PROTEIN MULTICALIBRATORJIX1998-05-07
1071811930491819K963424OLYMPUS LIPASE REAGENTCDT1997-01-14
1071811752523137K963139OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENTDDD1997-02-06
1071811288194541K962582OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENTDBI1996-10-18
1071811693065620K962409OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENTCZW1996-10-18
1368631694781533K961274OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZERJJE1996-07-05
1071811308699720K954825ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERJLW1995-11-21
1071811359440339K954537OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENTDCN1996-02-14
1071811157739754K952466OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENTJHN1995-06-05
1071811525759193K952425OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENTJHN1995-07-05
1071811970103889K944407OLYMPUS MAGNESIUM REAGENTJGJ1994-12-27
1071811455841107K926320REFLAB SYSTEM PACK LIQUID CO2 REAGENTCHS1993-02-03
1071811766184639K925339OLYLMPUS ALANINE AMINOTRANSFERASE REAGENTCKA1993-02-05
1071811020853032K925156OLYMPUS ALKALINE PHOSPHATASE REAGENTCJE1992-11-18
1071811112608555K925155OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENTCIT1993-01-26
1071811676307481K925057OLYMPUS INORGANIC PHOSPHORUS REAGENTCEO1992-11-19
1071811140557472K924964OLYMPUS TOTAL BILIRUBIN REAGENTCIG1992-12-03
1071812005347863K924963OLYMPUS DIRECT BILIRUBIN REAGENTCIG1992-11-30
1071811397432442K924693OLYMPUS BUN REAGENTCDQ1992-11-25
1071811461871252K924692OLYMPUS CREATININE REAGENTCGX1992-10-19
1071811914619583K924691OLYMPUS IRON REAGENTJIY1992-12-18
1071811729267608K924601OLYMPUS GLUCOSE REAGENTCFR1992-12-03
1071811030196049K924435OLYMPUS CALCIUM REAGENTCIC1992-10-19
1071811404855384K924339OLYMPUS AMYLASE REAGENTCIW1992-10-19
1071811420461832K922369OLYMPUS ALBUMIN REAGENTCIX1992-07-17
1071691617304067K921718OLYMPUS ISE MODULEJGS1992-07-21
1071811617304067K921718OLYMPUS ISE MODULEJGS1992-07-21
1071691474044547K893628OLYMPUS ISE MODULE FOR AU5000CGZ1989-08-11
1071691425208880K885193OLYMPUS ISE MODULECGZ1989-02-03
52611247474636K254059Access anti-HBc IgMSEI2026-03-13
52611627647815K253687Access anti-HBc TotalSEI2026-02-19
52611059034019K251995Access anti-HAV IgMLOL2026-01-27
52611263694360K243846Access anti-HAVLOL2025-09-09
52611727798045K240469Access TPO AntibodyJZO2024-08-09
52611013555339K232791Access Intact PTHCEW2024-03-01
3081571413715444K232600DxFLEX Flow Cytometer; ClearLLab 10C PanelsOYE2023-11-22
3395931413715444K232600DxFLEX Flow Cytometer; ClearLLab 10C PanelsOYE2023-11-22
52611911037596K223679Access AMHPQO2023-02-03
52611007533698K223503Access 25(OH) Vitamin D TotalMRG2023-01-19
3198181608405102K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS2023-07-20
1071811481867563K220178Total Immunoglobulin E (IgE)DGC2022-03-23
52611696682877K192271Access PCT, Access PCT CalibratorsPTF2019-11-26
1071631272499885K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12CDD2019-10-04
52611975121224K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerPWD2019-03-21
3081571975121224K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerPWD2019-03-21
1071811527142987K182651HbA1c AdvancedPDJ2019-01-16
3428681595632936K181475DxH 520 Hematology InstrumentGKZ2019-03-01
52612043571663K170524Access AMHPQO2017-11-13
1368631289721692K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerJGS2016-12-16
1071812032018229K161508CeruloplasminDDB2017-01-09
52611190378825K142373Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. SystMRG2014-12-22
52611770862966K142362Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.MRG2014-12-19
1071811836599537K142346Urine/CSF Albumin, Urine/CSF Albumin CalibratorDCF2014-10-15
1071811699637229K141388SYSTEM CALIBRATERJIX2014-07-11
1071811814950981K141374BICARBONATE CALIBRATORJIT2014-06-30
1071631985893517K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System ReagentsCDD2014-09-16
1071811891030027K131546AU BICARBONATE REAGENTKHS2013-10-09
1071811609741981K120199GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRYLCP2012-10-12
52611117130965K112603ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMSJJX2011-11-04
1368631220160979K112412AU5800(R) CHEMISTRY ANALYZERCEM2011-12-23
52611013694152K111952ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033JIT2011-08-19
1071631192325637K110413POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONSCDD2011-05-11
1071811824617850K103373SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722DIH2011-02-07
1071811780048268K092505BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203DBF2009-12-11
1071811511259849K091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORDCF2010-04-29
52611331440856K081526FLOWCARE TLG REAGENTGKZ2008-08-14
1071811926091620K080435OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181CIG2008-09-05
1071811935662050K073490OLYMPUS IGG REAGENTCFN2008-02-11
1071811103095458K073489OLYMPUS IGA REAGENTCFN2008-02-11
1071811728041107K073487OLYMPUS IGM REAGENTCFN2008-02-11
1071811703399856K070835OLYMPUS CK-MB REAGENTJHY2007-06-04
1071811888496186K070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLGHH2007-06-11
1071811811720486K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMCDT2007-03-23
1071811628369348K062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98KNK2007-04-06
1071811582787798K061575OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117CJY2006-10-05
52611427436130K061382ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227JZO2006-07-06
52611094367459K061190ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953CEW2006-09-15
1071811460608844K060201OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.DHR2006-06-06
1071811458323327K051564OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGHNQD2005-08-22
1071811036600272K043460OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071JIX2005-01-31
1071811106733117K043202OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279CGS2004-12-23
52611995270517K042651FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMSJIT2004-10-05
1071811787027398K042281MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAYJLW2004-09-16
1071811466927204K041793OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524JMO2004-07-16
1071811249064148K040692OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023JIT2004-04-08
1071811248104111K040471OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024JIT2004-03-10
1071811243117943K033910OLYMPUS URINE CALIBRATORJIX2004-01-30
1071811938564648K032285OLYMPUS PREALBUMIN CALIBRATOR, ODR3029JIT2003-08-21
1071811548514417K031380OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)LCP2003-11-14
1071811696103104K030045OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)DIH2003-02-21
52611003369894BK230961
52611205360449BK230833
1368631338456696BK180292
1071691293076845BK060024
1368631293076845BK060024
52611892500833BK010044
1071811654937848
1071691000924558
1071811007533698
1071811013555339
1071811054552816
1071811059034019
1071811075537151
3198181082688856
1071811094367459
1071811105350826
1071811105832175
52611150756138
1071811167169268
52611181568684
3081571181568684
1071811190378825
1071811192684944
1071811205360449

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JIT62014-06-30
JGS52023-07-20
JIX52014-07-11
MRG32023-01-19
CDD32019-10-04
CIG32008-09-05
CFN32008-02-11
SEI22026-03-13
LOL22026-01-27
JZO22024-08-09
CEW22024-03-01
OYE22023-11-22
PQO22023-02-03
PWD22019-03-21
GKZ22019-03-01
DCF22014-10-15
LCP22012-10-12
DIH22011-02-07
CDT22007-03-23
JLW22004-09-16
JHN21995-07-05
CGZ21989-08-11
DGC12022-03-23
PTF12019-11-26
PDJ12019-01-16
DDB12017-01-09
KHS12013-10-09
CEM12011-12-23
JJX12011-11-04
DBF12009-12-11
GHH12007-06-11
JHY12007-06-04
KNK12007-04-06
CJY12006-10-05
DHR12006-06-06
NQD12005-08-22
CGS12004-12-23
JMO12004-07-16
DEM11999-11-24
JZG11999-05-11