Jason Bilobram

FDA Filings

This page includes the latest FDA filings for Jason Bilobram. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003539867
FEI Number3006769061
NameJason Bilobram
Owner & OperatorSEKISUI MEDICAL CO., LTD.
Contact Address1-3, Nihonbashi 2-chome Chuo-ku
Tokyo JP-13 Tokyo 103-0027 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressOne Wall Street
Burlington, MA 01803 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number8020316
FEI Number3002806809
NameJason Bilobram
Owner & OperatorSekisui Diagnostics, LLC
Contact Address6659 Top Gun Street
San Diego CA 92121 US
Official Correspondent
  • Shelly Gallup
  • 1-858-7772627-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressOne Wall Street
Burlington, MA 01803 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device
  • Export Device to the United States But Perform No Other Operation on Device



Registration Number3006786407
FEI Number3002806840
NameJASON BILOBRAM
Owner & OperatorSEKISUI MEDICAL CO., LTD.
Contact Address1-3, Nihonbashi 2-chome Chuo-ku
Tokyo JP-13 Tokyo 103-0027 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressOne Wall Street
Burlington, MA 01803 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Jason Bilobram [Sekisui Diagnostics, LLC]
DC Trols Levels 1 and 22020-01-14
Jason Bilobram [Sekisui Diagnostics, LLC]
Acetaminophen L3K Assay2019-08-29
Jason Bilobram [Sekisui Diagnostics, LLC]
Acetaminophen Assay2019-08-29
Jason Bilobram [Sekisui Diagnostics, LLC]
HbA1c Assay2018-09-19
Jason Bilobram [Sekisui Diagnostics, LLC]
HbA1c Assay2018-09-19
Jason Bilobram [Sekisui Diagnostics, LLC]
HbA1c Controls2018-09-19
Jason Bilobram [Sekisui Diagnostics, LLC]
HbA1c Calibrators2018-09-19
Jason Bilobram [Sekisui Diagnostics, LLC]
HbA1c Blank Solution2018-09-19
Jason Bilobram [Sekisui Diagnostics, LLC]
Uric Acid Assay2018-08-09
Jason Bilobram [Sekisui Diagnostics, LLC]
DC-UIBC-Cal Calibrator2017-01-26
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
Lipase Color Activator; Lipase Color Calibrator; Lipase Color Reagent; Lipase Color Solvent2015-01-29
Jason Bilobram [Sekisui Diagnostics, LLC]
Carbon Dioxide Standard2014-05-20
Jason Bilobram [Sekisui Diagnostics, LLC]
Lipase color calibrator2013-05-07
Jason Bilobram [Sekisui Diagnostics, LLC]
Magnesium Reagent2012-01-16
Jason Bilobram [Sekisui Diagnostics, LLC]
Magnesium Assay2012-01-16
Jason Bilobram [Sekisui Diagnostics, LLC]
Iron PC SL2011-03-24
Jason Bilobram [Sekisui Diagnostics, LLC]
ALT-SL2011-03-21
Jason Bilobram [Sekisui Diagnostics, LLC]
GGT Assay2011-03-21
Jason Bilobram [Sekisui Diagnostics, LLC]
Direct Bilirubin SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Total Bilirubin SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Phosphorous SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Aspartate Amino Transferase SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Gamma Glutamyltranspepidase2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Gamma Glutamyltranspepidase L3K2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Creatine Kinase SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Creatine Kinase Assay2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Iron SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Micro Total Protein2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Unsaturated Iron Binding Complex2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
UIBC-SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Iron2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Uric Acid SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Uric Acid Assay2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Glucose SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Triglyceride2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Ammonia Assay2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
DC-UIBC Lineate2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Calcium Assay2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
DC Cal Calibrators2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Glucose2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
DC Trols2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Total Bilirubin2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Direct Bilirubin2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Albumin Assay2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Total Protein2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Cholesterol SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Cholesterol Assay2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Total Bilirubin L3K2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Total Bilirubin L3K2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Acetaminophen L3K2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Enzymatic Creatinine2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Magnesium2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
C-Reactive Protein Calibrator Set2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
C-Reactive Protein Assay2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Microalbumin Assay2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Carbon Dioxide L3K2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Acetaminophen2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Acetaminophen SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Acetaminophen Cal2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Salicylate2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Salicylate SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Salicylate Cal2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Microalbumin Multicalibrator Set2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Ammonia L3K2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Glucose SL C2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Total Bilirubin SL X2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Alkaline Phosphatase SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Urea L3K2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Carbon Dioxide L3K C2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Ethanol L3K2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Creatinine-S Assay2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Alanine Amino Transferase-SL2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Alanine Amino Transferase L3K2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Lactate Dehydrogenase2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
Lactate Dehydrogenase Assay2011-02-25
Jason Bilobram [Sekisui Diagnostics, LLC]
N-Geneous LDL-ST Reagent & Calibrator2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
N-Geneous LDL-ST Reagent & Calibrator2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
N-Geneous LDL-ST Reagent & Calibrator2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
N-Geneous LDL Cholesterol Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
N-Geneous LDL Cholesterol Calibrator2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
LDL Direct Liquid Select Cholesterol Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
N-Geneous LDL Cholesterol Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
N-Geneous LDL Cholesterol Calibrator2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
LDL Direct Liquid Select Cholesterol Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
N-Geneous LDL Cholesterol Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
N-Geneous LDL Cholesterol Calibrator2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
LDL Direct Liquid Select Cholesterol Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Liquid N-Geneous HDL Cholesterol Kit/ Cal2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Liquid N-Geneous HDL Cholesterol Kit/ Cal2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Ultra Sensitive Calibrator2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
CRP Ultra Wide Range Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Ultra N-Geneous HDL Cholesterol Reagent & Calibrator2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
HDL Ultra Cholesterol Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Ultra N-Geneous HDL Cholesterol Reagent & Calibrator2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
HDL Ultra Cholesterol Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
a-Amylase Test Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Liquid Select Amylase Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Amylase Assay2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Lipase Color Solvent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Lipase Color Reagent2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Lipase Color Calibrator2011-02-24
Jason Bilobram [Sekisui Diagnostics, LLC]
Lipase Color Activator2011-02-24
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL-ST CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL-ST CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL-ST CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
LIQUID N-GENEOUS HDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
KIT/CALIBRATOR2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
LIQUID N-GENEOUS HDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
KIT/CALIBRATOR2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
ULTRA N-GENEOUS HDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
ULTRA N-GENEOUS HDL CHOLESTEROL2008-05-22

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