Data / Medical devices / Japan / Denka Co., Ltd.

Denka Co., Ltd.: FDA-registered device maker in GOSEN-SHI Niigata, Japan, 6 510(k) clearances

Name: Denka Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Denka Co., Ltd. is registered with the FDA (registration 3003871639) in GOSEN-SHI Niigata, Japan. It lists 18 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 18, 2017. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Denka Co., Ltd.

FDA registration number: 3003871639
Address: 1359-1, Kagamida, Kigoshi, GOSEN-SHI Niigata, Japan, 959-1695
Owner or operator: DENKA CO., LTD. (9053049)
Roles: Contract manufacturer, Manufacturer
First device listed: March 30, 2006
Registered through: 2026
Brand names listed: ARCHITECT (R) INSULIN REAGENTS, Alinity i Insulin Reagent Kit, ARCHITECT Insulin Calibrators, ARCHITECT Insulin Controls, ARCHITECT iPhenytoin Calibrators (A-F), ARCHITECT iPhenytoin Immunoassay, ARCHITECT iValproic Acid Assay, ARCHTECT iPhenobarbital, Alinity c Rheumatoid Factor Calibrator Kit and more

Devices it lists

Device	Product code	Class	Role	Source
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Contract manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Diphenylhydantoin	DIP	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phenobarbital	DLZ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Valproic Acid	LEG	2	Manufacturer	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Contract manufacturer	accessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	LGR	2	Manufacturer	accessdata.fda.gov
Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test	PYP	1	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Immunoreactive Insulin	CFP	1	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Contract manufacturer	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Contract manufacturer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 18, 2017	K161679	s LDL-EX SEIKEN	PYP	Substantially Equivalent	Denka Seiken Co., Ltd.	accessdata.fda.gov
August 6, 2009	K090358	ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35	LEG	Substantially Equivalent	Abbott Laboratories, Inc.	accessdata.fda.gov
September 26, 2008	K081231	ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33	DLZ	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
September 11, 2008	K080696	ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01	DIP	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
June 2, 2003	K030546	CRP (II) CALIBRATORS	JIS	Substantially Equivalent	Denka Seiken Co., Ltd.	accessdata.fda.gov
June 2, 2003	K030545	CRP-LATEX (II)X2 SEIKEN ASSAY KIT	DCK	Substantially Equivalent	Denka Seiken Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 18, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.