Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003539867

FEI Number

3006769061

Entity Name

SEKISUI MEDICAL CO., LTD. Tsukuba Plant

City/State/Country

Ryugasaki-shi Ibaraki, JP

Establishment Address

3-1, KOYODAI 3-CHOME, Ryugasaki-shi Ibaraki 301-0852, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SEKISUI MEDICAL CO., LTD. (Owner Number: 9030526)

Owner / Operator Contact Address

1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, JP-13 103-0027, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR N-GENEOUS LDL CHOLESTEROL Lipase Color Activator; Lipase Color Calibrator; Lipase Color Reagent; Lipase Color Solvent N-GENEOUS LDL-ST CHOLESTEROL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2021-12-13
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2008-05-22
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-05-22
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-05-22
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-05-22
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2008-05-22
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2015-01-29
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-05-22
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2008-05-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-05-22

Official Correspondent

Motoko Matsufuji

US Agent Details

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

Related Public Records

Same Entity

SEKISUI MEDICAL CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006850222	SEKISUI MEDICAL CO., LTD. Tokuyama Plant	Shunan-City Yamaguchi, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16
K103548	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	2011-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021	Siemens Healthcare Diagnostics, Inc.	2	Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

Similar Registrations

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3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
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2122870	BECKMAN COULTER, INC.	CHASKA, MN, US
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003539867. Last updated year: 2026. Please use registration number 3003539867 when referencing this establishment in official correspondence.