Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003871639

FEI Number

3003871639

Entity Name

DENKA CO., LTD.

City/State/Country

GOSEN-SHI Niigata, JP

Establishment Address

1359-1, KAGAMIDA, KIGOSHI, GOSEN-SHI Niigata 959-1695, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DENKA CO., LTD. (Owner Number: 9053049)

Owner / Operator Contact Address

1359-1, KAGAMIDA, KIGOSHI, GOSEN-SHI, JP-15 959-1695, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090358

PMA Number

N/A

All Registered Proprietary Names

ARCHTECT iPhenobarbital s LDL-EX "SEIKEN" small dense LDL Seiken VCP ASO/RF PVs & CALI KIT 28 BMG Latex X1 & Calibrator Set F CRP (II) Calibrators Immuno Q-Sera II Urine Protein Control Alinity i Insulin Controls ARCHITECT Insulin Calibrators ARCHITECT Insulin Controls FERRITIN, ANTIGEN, ANTISERUM, CONTROLCalibrator, secondary VCP RHEUMATOID FACTOR CALIBRATOR KIT 16 CRP-Latex (II) X2 SEIKEN Assay Kit Rheumatoid Factor Calibrator Rheumatoid Factor Test Kit VCP LIPID CALIBRATOR KIT 19 ARCHITECT iPhenytoin Immunoassay ARCHITECT iPhenytoin Calibrators (A-F) ARCHITECT iValproic Acid Assay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2008-10-22
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2008-10-22
PYP	Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test	Clinical Chemistry	Class 1	862.1475	2018-02-28
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2012-03-11
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2018-12-25
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-05-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-11-06
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2012-03-08
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-03-08
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2012-03-11
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2008-05-07
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2011-05-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-03-11
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-03-11
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2012-03-11
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2008-09-19
LGR	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	Clinical Toxicology	Class 2	862.3350	2008-09-19
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2009-08-24
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2009-08-24

Official Correspondent

No official correspondent registered.

US Agent Details

Sheila W. Pickering Email: sheilawalsh@alumni.stanford.edu Phone: (650) 2790668

Related Public Records

Same Entity

DENKA CO., LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780731	Vitek Systems, Inc.	LIDOCAINE CALIBRATOR KIT	1979-01-17
K833380	E.I. Dupont DE Nemours & Co., Inc.	LIDOAINE CALIBRATOR	1983-12-27
K760096	Gamma Biologicals, Inc.	REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O	1976-08-03
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2013	Siemens Healthcare Diagnostics, Inc.	2	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Z-0023-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022	Sentinel CH SpA Via Robert Koch	2	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0128-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)

Similar Registrations

Registration Number	Establishment Name	Location
3005333358	ABBOTT LABORATORIES	Lake Forest, IL, US
3003610499	LIN-ZHI INTERNATIONAL, INC.	Santa Clara, CA, US
2050010	BECKMAN COULTER, INC.	CARLSBAD, CA, US
1220972	MEDICA CORP.	BEDFORD, MA, US
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003871639. Last updated year: 2026. Please use registration number 3003871639 when referencing this establishment in official correspondence.