Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020316

FEI Number

3002806809

Entity Name

Sekisui Diagnostics P.E.I. Inc.

City/State/Country

CHARLOTTETOWN Prince Edward Island, CA

Establishment Address

70 Watts Avenue, CHARLOTTETOWN Prince Edward Island C1E 2B9, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sekisui Diagnostics, LLC (Owner Number: 10035388)

Owner / Operator Contact Address

6659 Top Gun Street, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070383

PMA Number

N/A

All Registered Proprietary Names

Creatine Kinase Assay Creatine Kinase SL Total Protein Microalbumin Multicalibrator Set DC Cal Calibrators HbA1c Controls Acetaminophen Cal Acetaminophen Acetaminophen SL Salicylate Cal Salicylate Salicylate SL Uric Acid Assay Carbon Dioxide L3K C Microalbumin Assay Gamma Glutamyltranspepidase Gamma Glutamyltranspepidase L3K Liquid N-Geneous HDL Cholesterol Kit/ Cal Amylase Assay Liquid Select Amylase Reagent a-Amylase Test Reagent Aspartate Amino Transferase SL Calcium Assay Iron SL Creatinine-S Assay DC Trols Levels 1 and 2 N-Geneous LDL-ST Reagent & Calibrator Direct Bilirubin ALT-SL N-Geneous LDL Cholesterol Calibrator N-Geneous LDL Cholesterol Reagent LDL Direct Liquid Select Cholesterol Reagent Albumin Assay Phosphorous SL Magnesium Unsaturated Iron Binding Complex UIBC-SL Acetaminophen L3K Assay Acetaminophen Assay Ammonia L3K Glucose SL C Magnesium Assay Magnesium Reagent Iron PC SL Triglyceride Lipase color calibrator CRP Ultra Wide Range Reagent Ultra Sensitive Calibrator Ultra N-Geneous HDL Cholesterol Reagent & Calibrator HDL Ultra Cholesterol Reagent Uric Acid Assay Uric Acid SL Cholesterol Assay Cholesterol SL Carbon Dioxide Standard Urea L3K HbA1c Blank Solution HbA1c Calibrators Enzymatic Creatinine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2011-02-25
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2011-02-25
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2012-02-01
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-02-01
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-02-01
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2012-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2011-02-25
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2024-05-15
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2011-02-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-09-19
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-02-01
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2011-02-25
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2011-02-25
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2018-08-09
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2011-02-25
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2014-01-28
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2014-01-28
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2012-12-21
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2011-02-25
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2011-02-25
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-02-24
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2011-02-24
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2024-05-15
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2024-05-15
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2012-12-21
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2011-02-24
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2016-11-14
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2016-11-14
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2021-04-23
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2024-05-15
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2024-05-15
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2011-02-25
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2011-02-25
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2011-02-25
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-02-25
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2020-01-14
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2011-02-24
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-02-24
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-02-24
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2011-02-25
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2011-03-21
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-02-01
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-03-21
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-02-24
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2011-02-24
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2011-02-24
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2012-12-06
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2011-02-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-02-01
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2013-02-01
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2011-02-25
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2015-07-24
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-07-24
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-07-24
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2015-07-24
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2011-02-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-02-01
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2013-02-01
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2011-02-25
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2013-02-01
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2014-04-02
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2014-04-02
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-04-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-04-02
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2019-08-29
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2018-06-28
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2011-02-25
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2023-01-13
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-02-25
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2012-01-16
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2011-03-24
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-02-01
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2011-02-25
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2013-05-07
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2024-05-15
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2011-02-24
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-12-23
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-02-24
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2012-12-21
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-02-24
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2011-02-24
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2011-02-25
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-05-03
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2018-05-03
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2024-08-19
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2024-08-19
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2011-02-25
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2021-04-23
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-05-20
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2011-02-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-09-19
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-02-25

Official Correspondent

No official correspondent registered.

US Agent Details

Jason Bilobram Business: Sekisui Diagnostics, LLC Email: jason.bilobram@sekisuidiagnostics.com Phone: (781) 6527848

Related Public Records

Same Entity

Sekisui Diagnostics, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017772438	Sekisui Diagnostics, LLC	San Diego, CA, US
2030538	Sekisui Diagnostics, LLC	SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K820880	Miles Laboratories, Inc.	SERALYZER CK REAGENT STRIPS	1982-04-16
K771441	Instrumentation Laboratory CO	MULTISTAT III CPK TEST	1977-08-22
K861663	Data Medical Associates, Inc.	TOTAL PROTEIN PROCEDURE	1986-06-13
K832169	Sandare Chemical Co., Inc.	TOTAL PROTEIN PROCEDURE	1983-08-16
K771476	Instrumentation Laboratory CO	MULTISTAT III TOTAL PROTEIN TEST	1977-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0139-2011	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
Z-0148-2020	Siemens Healthcare Diagnostics, Inc.	2	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020316. Last updated year: 2026. Please use registration number 8020316 when referencing this establishment in official correspondence.