NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER

Registration Details

Registration Name: NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER
Registration Number: 1000403749
FEI Number: 1000403749
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 1, Shiojima, Fukuhara, Fukuyama
City: Koriyama Fukushima
Country: JP

Regulatory Submissions

510(k) Number: K993480

Owner / Operator

Firm Name: Nittobo Medical Co., Ltd.
Operator Number: 9028746
Address: 1, Shiojima, Fukuhara, Fukuyama
City: Koriyama
State: Fukushima
Postal Code: 963-8061
Country: JP

US Agent

Business Name: Kamiya Biomedical Company
Contact Name: Colin Getty
Address: 12779 Gateway Drive S.
City: Tukwila
State: WA
ZIP: 98168
Country: US
Email: [email protected]
Phone: 206 3905224

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	Class 2	Immunology	No	2008-01-31
Haptoglobin, Antigen, Antiserum, Control	DAD	Class 2	Immunology	No	2008-01-31
Igm, Antigen, Antiserum, Control	DFT	Class 2	Immunology	No	2016-10-27
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	Class 2	Clinical Chemistry	No	2016-10-27
Alpha-1-Lipoprotein, Antigen, Antiserum, Control	DER	Class 2	Immunology	No	2008-01-31
Complement C3, Antigen, Antiserum, Control	CZW	Class 2	Immunology	No	2016-10-27
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	Class 2	Immunology	No	2025-05-28
Igg, Antigen, Antiserum, Control	DEW	Class 2	Immunology	No	2008-01-31
Transferrin, Antigen, Antiserum, Control	DDG	Class 2	Immunology	No	2016-10-27
Complement C4, Antigen, Antiserum, Control	DBI	Class 2	Immunology	No	2016-10-27
Calibrator, Primary	JIS	Class 2	Clinical Chemistry	No	2008-01-31
Test, Fibrinogen	GIS	Class 2	Hematology	No	2008-01-31
Multi-Analyte Controls, All Kinds (Assayed)	JJY	Class 1	Clinical Chemistry	No	2008-01-31
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	Class 1	Clinical Chemistry	No	1998-05-13
Calibrator, Multi-Analyte Mixture	JIX	Class 2	Clinical Chemistry	No	2008-01-31
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	Class 2	Immunology	No	2008-01-31
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	LKL	Class 1	Immunology	No	2008-01-31
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	Class 2	Clinical Chemistry	No	2016-10-27
System, Test, Rheumatoid Factor	DHR	Class 2	Immunology	No	2020-10-23
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2010-12-03
Calibrator, Secondary	JIT	Class 2	Clinical Chemistry	No	2010-12-03
Test, Cystatin C	NDY	Class 2	Clinical Chemistry	No	2010-12-03
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	Class 1	Microbiology	No	1997-05-02
Iga, Antigen, Antiserum, Control	CZP	Class 2	Immunology	No	2012-04-02
Prealbumin, Antigen, Antiserum, Control	JZJ	Class 1	Immunology	No	1998-04-13
Immunoelectrophoretic, Immunoglobulins, (G, A, M)	CFF	Class 2	Immunology	No	2008-01-31
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	Class 1	Clinical Chemistry	No	2019-04-09
Albumin, Antigen, Antiserum, Control	DCF	Class 2	Immunology	No	2012-02-23
Colorimetric Method, Gamma-Glutamyl Transpeptidase	JPZ	Class 1	Clinical Chemistry	No	2016-10-27
Photometric Method, Magnesium	JGJ	Class 1	Clinical Chemistry	No	2019-11-14

Proprietary Names

N-ASSAY TIA Apo AI K-ASSAY Apo AI K-ASSAY CRP (Ver.2) K-ASSAY Fibrinogen K-ASSAY Apo B K-ASSAY CRP Calibrator

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device